FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION CLIP DEVICE
MDR report key: 1200093
·
Received October 15, 2008
Report
- Report Number
- 3005099803-2008-05277
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 15, 2008
- Report Date
- September 15, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- PMA / PMN Number
- K040148
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER IS UNAVAILABLE; THEREFORE, MANUFACTURER AND EXPIRATION DATE CANNOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY, TWO SEPARATE RESOLUTION CLIP DEVICES WERE USED TO STOP A GASTRIC BLEED, BUT NEITHER CLIP WOULD DEPLOY. A THIRD RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATION. PATIENT IS "OK". NOTE: THIS COMPLAINT IS FOR ONE OF TWO DEVICES, PLEASE REFER TO MFR#'S 3005099803-2008-05278 FOR RELATED REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESOLUTION CLIP DEVICE | MND | BOSTON SCIENTIFIC CORPORATION | M00522610 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |