RESOLUTION CLIP
Report
- Report Number
- 3005099803-2025-00500
- Event Type
- Malfunction
- Date Received
- February 13, 2025
- Date of Event
- January 20, 2025
- Report Date
- June 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PKL
- UDI-DI
- 08714729504795
- PMA / PMN Number
- K142973
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION. BLOCK A2 (AGE AT TIME OF EVENT, UNIT OF MEASURE - AGE, SEX, GENDER), BLOCK B5 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025.
BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION.
BLOCK G4 (PREMARKET / 510(K) #): K222503 BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION. BLOCK A2 (AGE AT TIME OF EVENT, UNIT OF MEASURE - AGE, SEX, GENDER), BLOCK B5 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025. BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025.
BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION. BLOCK A2 (AGE AT TIME OF EVENT, UNIT OF MEASURE - AGE, SEX, GENDER), BLOCK B5 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025. BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025. BLOCK H11: A RESOLUTION CLIP WAS RECEIVED FOR ANALYSIS. THE DEVICE WAS RETURNED WITHOUT ITS OUTER SHEATH, WITH THE CLIP ASSEMBLY DETACHED BUT STILL ON THE CONTROL WIRE, SHOWING SIGNS OF SOFT DEPLOYMENT; THE FIRST ACTIVATION WAS NOT PERFORMED, AND A PHOTO OF THE DEVICE IN ITS POUCH WAS PROVIDED. NO OTHER DEVICE PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF CLIP UNABLE TO RELEASE FROM CATHETER WAS CONFIRMED. UPON ANALYSIS, THE DEVICE WAS RETURNED WITH SIGNS OF A SOFT DEPLOYMENT AND HAD NOT BEEN ACTIVATED. THIS MEANS THE CAPSULE CAME LOOSE FROM THE BUSHING AND COULD NO LONGER OPEN OR CLOSE PROPERLY. THE SOFT DEPLOYMENT MIGHT HAVE HAPPENED BECAUSE OF HOW THE DEVICE WAS INSERTED INTO THE SCOPE, HOW THE DOCTOR USED IT, OR FROM AN UNKNOWN IMPACT DURING SETUP. THE CAPSULE MAY HAVE DETACHED BECAUSE SOMETHING HIT THE JOINT WITH FORCE. BASED ON THE INFORMATION AVAILABLE AND THE RETURNED DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CLIP WAS OPENED FOR THE SECOND TIME, IT DETACHED FROM THE ADJUSTMENT SYSTEM, AND IT DID NOT ALLOW IT TO ATTACH TO THE FABRIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025: IT WAS CLARIFIED THAT THE MAIN PROBLEM OF THE DEVICE THAT THE CLIP WAS POSITIONED OVER THE TARGET ULCER AND INITIALLY CATCHES IT, BUT THE TISSUE SLIPS OFF. THE CLIP WAS THEN REOPENED, AND ON THE SECOND ATTEMPT TO CLOSE IT, IT COMES LOOSE WITHOUT SECURING THE TISSUE. IT WAS NOTED THAT THE TYPE OF PROCEDURE WAS COLONOSCOPY.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CLIP WAS OPENED FOR THE SECOND TIME, IT DETACHED FROM THE ADJUSTMENT SYSTEM, AND IT DID NOT ALLOW IT TO ATTACH TO THE FABRIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS 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 WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CLIP WAS OPENED FOR THE SECOND TIME, IT DETACHED FROM THE ADJUSTMENT SYSTEM, AND IT DID NOT ALLOW IT TO ATTACH TO THE FABRIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025: IT WAS CLARIFIED THAT THE MAIN PROBLEM OF THE DEVICE THAT THE CLIP WAS POSITIONED OVER THE TARGET ULCER AND INITIALLY CATCHES IT, BUT THE TISSUE SLIPS OFF. THE CLIP WAS THEN REOPENED, AND ON THE SECOND ATTEMPT TO CLOSE IT, IT COMES LOOSE WITHOUT SECURING THE TISSUE. IT WAS NOTED THAT THE TYPE OF PROCEDURE WAS COLONOSCOPY. ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025: IT WAS CONFIRMED THAT THE PATIENT UNDERWENT AN UPPER GASTROINTESTINAL ENDOSCOPY AND COLONOSCOPY.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CLIP WAS OPENED FOR THE SECOND TIME, IT DETACHED FROM THE ADJUSTMENT SYSTEM, AND IT DID NOT ALLOW IT TO ATTACH TO THE FABRIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025: IT WAS CLARIFIED THAT THE MAIN PROBLEM OF THE DEVICE THAT THE CLIP WAS POSITIONED OVER THE TARGET ULCER AND INITIALLY CATCHES IT, BUT THE TISSUE SLIPS OFF. THE CLIP WAS THEN REOPENED, AND ON THE SECOND ATTEMPT TO CLOSE IT, IT COMES LOOSE WITHOUT SECURING THE TISSUE. IT WAS NOTED THAT THE TYPE OF PROCEDURE WAS COLONOSCOPY. ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025: IT WAS CONFIRMED THAT THE PATIENT UNDERWENT AN UPPER GASTROINTESTINAL ENDOSCOPY AND COLONOSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1461135 | RESOLUTION CLIP | CLIP, HEMOSTATIC | PKL | BOSTON SCIENTIFIC CORPORATION | M00522610 | 0033033797 | 08714729504795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |