FDA Adverse Event
Malfunction
Summary report: N
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
MDR report key: 2890681
·
Received December 31, 2012
Report
- Report Number
- 3005099803-2012-06088
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HTA PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SYSTEM UNEXPECTEDLY WENT INTO THE ABLATION PHASE BEFORE THE PHYSICIAN WAS READY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PROCEDURE SET. THE PATIENT WAS REPORTED TO BE FINE AT THE CONCLUSION OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM | DEVICE, THERMAL ABLATION, ENDOMETRIAL | MNB | BOSTON SCIENTIFIC - MARLBOROUGH | UNK559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |