FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION KIT
MDR report key: 1133507
·
Received August 22, 2008
Report
- Report Number
- 3005099803-2008-03730
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 23, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE USING A PROLIEVE THERMODILITATION KIT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED ON TWO WEEKS EARLIER. ACCORDING TO THE COMPLAINANT, DURING COOL DOWN, IT WAS OBSERVED THAT A CATHETER BALLOON HAD RUPTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION KIT | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808022 | 0000606421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |