FDA Adverse Event
Malfunction
Summary report: N
HYDROTHERMABLATOR CONSOLE UNIT
MDR report key: 1203181
·
Received October 17, 2008
Report
- Report Number
- 3005099803-2008-05333
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 18, 2008
- Report Date
- September 19, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 9/19/08, THAT A HYDROTHERMABLATOR CONSOLE UNIT (HTA) WAS USED DURING A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE HTA FROZE AFTER A CASE. THE PROCEDURE WAS COMPLETED PRIOR TO THE HTA FREEZING. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROTHERMABLATOR CONSOLE UNIT | MNB | BOSTON SCIENTIFIC CORPORATION | M00656000R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |