SMARTABLATE · Cardiac Ablation Percutaneous Catheter
Biosense Webster Inc · Contamination /Decontamination Problem
- Manufacturer g1 address 2
- Colonia Ciudad Industrial
- Manufacturer contact t name
- Ms.
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Tijuana
- Manufacturer contact address 1
- 31 Technology Dr
- Manufacturer contact pcity
- +1(513)3
- Event type
- Malfunction
- Report number
- 3013300026-2026-03209
- Product problem flag
- Y
- Date received
- 20260930
- PMA pmn number
- P990071
- Date of event
- 20260901
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 92618
- Manufacturer contact plocal
- +1(513)337-8052
- Noe summarized
- 1
- Manufacturer contact l name
- Seppa
- Reporter country code
- US
- Date added
- 20260930
- Manufacturer contact f name
- Katie
- Previous use code
- I
- Reporter state code
- IN
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- N
- Summary report flag
- N
- Manufacturer contact city
- Irvine
- MDR report key
- 50941445
- Date manufacturer received
- 20260901
- Report source code
- Manufacturer report
- Manufacturer g1 name
- Harmac Medical Products
- Adverse event flag
- N
- Single use flag
- Y
- Manufacturer g1 address 1
- Maquiladoras No. 320-A
- Manufacturer contact postal code
- 92618
- Type of report
- Initial submission
- Source type
- Health Professional, Company representation
- Device
- Device sequence number
- 87403
- Date received
- 20260930
- Brand name
- SMARTABLATE
- Generic name
- Cardiac Ablation Percutaneous Catheter
- Manufacturer d name
- Biosense Webster Inc
- Manufacturer d address 1
- 31 Technology Drive, Suite 200
- Manufacturer d city
- Irvine
- Manufacturer d state
- CA
- Manufacturer d zip code
- 92618
- Manufacturer d country
- US
- Manufacturer d postal code
- 92618
- Device operator
- HEALTH PROFESSIONAL
- Catalog number
- SAT001
- Lot number
- 3017531
- Device availability
- No
- Device report product code
- LPB
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 10846835009743
- UDI public
- (01)10846835009743(17)261230(10)3017531
- Harmonized identifiers (openFDA)
- Device name
- Cardiac Ablation Percutaneous Catheter
- Medical specialty description
- Unknown
- Device class
- 3
- Product problems
- Contamination /Decontamination Problem
- Patient
- Patient sequence number
- 1
- Date received
- 20260930
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions