FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION CLIP DEVICE
MDR report key: 1203193
·
Received October 17, 2008
Report
- Report Number
- 3005099803-2008-05381
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- August 27, 2008
- Report Date
- September 19, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- PMA / PMN Number
- K040148
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON SEPTEMBER 19, 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, TWO RESOLUTION CLIP DEVICE CLIPS WERE CLOSED, BUT WOULD NOT DISENGAGE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. PATIENT IS "OKAY". NOTE: THIS COMPLAINT IS THE FIRST OF TWO DEVICES. REFER TO MFR #'S 3005099803-2008-05380 FOR THE OTHER RELATED REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESOLUTION CLIP DEVICE | MND | BOSTON SCIENTIFIC CORPORATION | M00522611 | 0ML8031003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |