FDA Adverse Event Malfunction Summary report: N

RESOLUTION CLIP CLIPPING DEVICE

MDR report key: 3864096 · Received June 10, 2014

Report

Report Number: 3005099803-2014-02194
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: May 16, 2014
Report Date: May 20, 2014
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KOG
PMA / PMN Number: K040148
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem · 1

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-02194 PERTAINS TO THE FIRST RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2014-02195 PERTAINS TO THE SECOND RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. ANOTHER CLIP WAS OPENED AND USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
338723	RESOLUTION CLIP CLIPPING DEVICE	ENDOSCOPE AND/OR ACCESSORIES	KOG	BOSTON SCIENTIFIC - MARLBOROUGH	M00522610	ML000656C3

Patients

Seq	Age	Sex	Outcome	Treatment
1