FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION 360 CLIP
MDR report key: 19960655
·
Received August 12, 2024
Report
- Report Number
- 3005099803-2024-03774
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- February 1, 2023
- Report Date
- August 12, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PKL
- UDI-DI
- 08714729875635
- PMA / PMN Number
- K222503
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF DEVICE ENTRAPMENT.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER THE CLIP WAS FIRED, THERE WAS A SMALL METAL PIECE THAT BROKE OFF AT THE END OF THE LINE THAT WAS FOUND INSIDE THE SCOPE AND REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2027270 | RESOLUTION 360 CLIP | HEMOSTATIC METAL CLIP FOR THE GI TRACT | PKL | BOSTON SCIENTIFIC CORPORATION | M00521231 | 0030120201 | 08714729875635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |