FDA Adverse Event
Malfunction
Summary report: N
HYDROTHERMABLATOR PROCEDURE SET
MDR report key: 1140586
·
Received August 28, 2008
Report
- Report Number
- 3005099803-2008-04180
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 1, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE HYDROTHERMAL ABLATION (HTA) PROCEDURE, WHILE USING THE HYDROTHERMABLATOR PROCEDURE SET, THE SHEATH CRACKED. HALF WAY THROUGH THE ABLATION PHASE, A PORTION OF THE SHEATH (ONE HALF INCH FROM THE SCOPE ADAPTER) CRACKED AND HOT SALINE LEAKED OUT. THE PATIENT INDICATED FEELING "HOT", THE PATIENT WAS COOLED DOWN, NO SIGN OF PHYSICAL BURN WAS OBSERVED. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROTHERMABLATOR PROCEDURE SET | MNB | BOSTON SCIENTIFIC CORPORATION | M006560201 | 0000034330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |