FDA Adverse Event
Injury
Summary report: N
PROLIEVE THERMODILATATION KIT
MDR report key: 1080767
·
Received July 23, 2008
Report
- Report Number
- 3005099803-2008-01259
- Event Type
- Injury
- Date Received
- July 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
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
ON JUNE 23, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PATIENT UNDERWENT TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) WITH A PROLIEVE THERMODILATATION KIT IN 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT'S WIFE STATED THAT DURING THE PROCEDURE THE PROLIEVE CATHETER CUT THE PATIENT'S URETHRA. REPORTEDLY, THE PHYSICIAN ABORTED THE CASE. THE PATIENT'S CONDITION IS UNKNOWN. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILATATION KIT | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808022 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |