FDA Adverse Event
Malfunction
Summary report: N
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
MDR report key: 2070440
·
Received April 27, 2011
Report
- Report Number
- 2029046-2011-00032
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 9, 2011
- Report Date
- April 11, 2011
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER WAS NOT RETURNED TO BWI FOR INVESTIGATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER FINISHING THE ABLATION WITH CARTO 3 RMT SYSTEM, THE PHYSICIAN PULLED OUT THE CATHETER AND SAW CHARRING ON THE PROXYMAL END OF THE TIP ELECTRODE. THE CHAR WRAPPED AROUND THE CATHETER TIP FROM ONE SIDE TO THE OTHER SIDE FURTHER DOWN THE SHAFT. THERE WERE NO COMPLICATIONS WITH THE PATIENT DURING FOLLOW-UP VISIT. THE TOTAL RF TIME WAS 77 MINUTES 39 SECONDS FOR 135 RF APPLICATIONS AT 30 WATTS AND 17ML/MIN FLOWRATE. THE PHYSICIAN THINKS THAT THE CHARRING MIGHT HAVE OCCURRED DURING ABLATION NEAR THE LSPV OSTIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | BIOSENSE WEBSTER, INC (IRWINDALE) | D-1266-01-S | UNKNOWN_D-1266-01-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |