FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION KIT
MDR report key: 1161368
·
Received September 12, 2008
Report
- Report Number
- 3005099803-2008-04525
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 14, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED, 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
A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CATHETER LEAKED BETWEEN THE PROSTHETIC AND FOLEY ANCHORING BALLOONS. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PROLIEVE THERMODILITATION KIT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION KIT | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808022 | 0000606600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |