FDA Adverse Event
Injury
Summary report: N
CHILLI II ABLATION CATHETER
MDR report key: 2011619
·
Received March 9, 2011
Report
- Report Number
- 3001236349-2011-00013
- Event Type
- Injury
- Date Received
- March 9, 2011
- Report Date
- February 10, 2011
- Manufacturer
- BOSTON SCIENTIFIC - SAN JOSE
- Product Code
- LPB
- PMA / PMN Number
- P980003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED. DEVICE WAS NOT RETURNED
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS REPORTED IN AN ARTICLE: TWO PATIENTS REQUIRED PROLONGED VENTILATORY DEPENDENCE SECONDARY TO EXACERBATION OF HEART FAILURE SUPERIMPOSED ON CHRONIC PULMONARY DISEASE. THE ARTICLE INDICATES THE FOLLOWING: RF ENERGY (50 W MAXIMUM) WAS DELIVERED VIA AN 8-FR 3.5-MM-TIP OPEN-IRRIGATION CATHETER ((B)(4)) OR 8-FR 4-MM-TIP CLOSED-IRRIGATION CATHETER ((B)(4)). THE ARTICLE DOES NOT INDICATE WHICH CATHETER WAS USED IN THE PATIENTS WITH COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHILLI II ABLATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BOSTON SCIENTIFIC - SAN JOSE | UNK78 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O | CHILII II MDR ID 3001236349-2011-00012| CHILLI II MDR ID 3001236349-2011-00010 |