RESOLUTION 360 CLIP
Report
- Report Number
- 3005099803-2024-05417
- Event Type
- Malfunction
- Date Received
- October 28, 2024
- Date of Event
- August 23, 2024
- Report Date
- February 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PKL
- UDI-DI
- 08714729875642
- PMA / PMN Number
- K222503
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO RELEASE FROM CATHETER. BLOCK H11: ADDITIONAL INFORMATION A3B (GENDER), A4 (WEIGHT), A6 (RACE), E1 (INITIAL REPORTER ADDRESS), (INITIAL REPORTER CITY), (INITIAL REPORTER STATE), (INITIAL REPORTER ZIP CODE) HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 23, 2024. BLOCK B5 AND BLOCK H6 HAS BEEN UPDATED BASED ON THE CORRECTION IDENTIFIED ON JANUARY 16, 2025.
BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO RELEASE FROM CATHETER.
BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO RELEASE FROM CATHETER. BLOCK H11: ADDITIONAL INFORMATION A3B (GENDER), A4 (WEIGHT), A6 (RACE), E1 (INITIAL REPORTER ADDRESS), (INITIAL REPORTER CITY), (INITIAL REPORTER STATE), (INITIAL REPORTER ZIP CODE) HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 23, 2024.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH CLIPPING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP MALFUNCTIONED AND DID NOT FIRE CORRECTLY. NOO PATIENT COMPLICATIONS WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH CLIPPING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP MALFUNCTIONED AND DID NOT FIRE CORRECTLY. NOO PATIENT COMPLICATIONS WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH CLIPPING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP MALFUNCTIONED AND DID NOT FIRE CORRECTLY. NO PATIENT COMPLICATIONS WAS REPORTED AS A RESULT OF THIS EVENT. ** ADDITIONAL INFORMATION RECEIVED ON OCTOBER 23, 2024
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1891269 | RESOLUTION 360 CLIP | HEMOSTATIC METAL CLIP FOR THE GI TRACT | PKL | BOSTON SCIENTIFIC CORPORATION | M00521232 | 0032881012 | 08714729875642 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |