FDA Adverse Event Malfunction Summary report: N

RESOLUTION CLIP

MDR report key: 21721760 · Received March 28, 2025

Report

Report Number: 3005099803-2025-01322
Event Type: Malfunction
Date Received: March 28, 2025
Date of Event: March 1, 2025
Report Date: March 28, 2025
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: PKL
PMA / PMN Number: K142973
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. SECTION E: THIS EVENT WAS REPORTED BY THE SALES REPRESENTATIVE. THE HEALTHCARE FACILITY IS: (B)(6) BRAZIL (B)(6). PHONE: (B)(6). BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO DEPLOY.

Description of Event or Problem · 0

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE DEVICE ENCOUNTERED SIGNIFICANT CHALLENGES IN OPENING THE FLAPS FOR POSITIONING. POST-FIRING, IT DID NOT RELEASE FROM THE CLIPPER ROD AND SUBSEQUENTLY DETACHED FROM THE TISSUE, PROLONGING THE EXAMINATION TIME. TO MITIGATE THIS ISSUE, IT IS ESSENTIAL TO UTILIZE THE CLIP TO APPROXIMATE THE RESECTION EDGES. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2579682	RESOLUTION CLIP	CLIP, HEMOSTATIC	PKL	BOSTON SCIENTIFIC CORPORATION	M00522610

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown