FDA Adverse Event
Malfunction
Summary report: N
HYRDOTHERMABLATOR PROCEDURE SET
MDR report key: 1133511
·
Received August 22, 2008
Report
- Report Number
- 3005099803-2008-03715
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 23, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY, THE MFR AND EXPIRATION DATE OF THE DEVICE IS UNK. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, WE ARE NOT ABLE TO DETERMINE TO RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE IN 2008. DURING THE PROCEDURE, THE HTA RESERVOIR OVERHEATED AND MELTED. NO PATIENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYRDOTHERMABLATOR PROCEDURE SET | MNB | BOSTON SCIENTIFIC CORPORATION | M006560200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |