FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION KIT
MDR report key: 1222879
·
Received November 6, 2008
Report
- Report Number
- 3005099803-2008-06112
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 7, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
A PROLIEVE THERMODILITATION KIT WAS USED DURING A TRANSURETHRAL MICROWAVE THERMOTHERAPY (TUMT) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION THE ANCHORING BALLOON WOULD NOT INFLATE ONCE THE PROLIEVE CATHETER WAS PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILITATION KIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "OKAY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION KIT | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808022 | 0000607019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |