FDA Adverse Event
Malfunction
Summary report: N
HYRDOTHERMABLATOR CONSOLE UNIT
MDR report key: 1221507
·
Received November 5, 2008
Report
- Report Number
- 3005099803-2008-05943
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- August 22, 2008
- Report Date
- October 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, HYDROTHERMABLATOR (HTA) CONSOLE UNIT WAS USED DURING A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE PRODUCT FAILED, MACHINE SHUT DOWN AT START OF ABLATION. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE PATIENT OR THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYRDOTHERMABLATOR CONSOLE UNIT | MNB | BOSTON SCIENTIFIC CORPORATION | M006560000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |