FDA Adverse Event Malfunction Summary report: N

ROTATABLE SNARE

MDR report key: 3962821 · Received July 29, 2014

Report

Report Number: 3005099803-2014-02547
Event Type: Malfunction
Date Received: July 29, 2014
Report Date: July 9, 2014
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Product Code: FDI
PMA / PMN Number: K992477
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS HAS DETACHED. THE CATHETER HAD MARKS FROM THE FLARE PROCESS PERFORMED DURING MANUFACTURING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT THAT THE DEVICE WOULD NOT EXTEND WAS CONFIRMED; DUE TO THE FLARE DETACHMENT THE SNARE WAS UNABLE TO EXTEND OUT OF THE SHEATH. HOWEVER, THE INVESTIGATION FAILED TO INDICATE A POTENTIAL OR DEFINITE ROOT CAUSE FOR THIS COMPLAINT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS FLARE DETACHMENT ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SMALL OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO EXTEND OUT OF THE SHEATH INSIDE THE PATIENT¿S LARGE INTESTINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
441931	ROTATABLE SNARE	SNARE, FLEXIBLE	FDI	BOSTON SCIENTIFIC - COSTA RICA (COYOL)	M00561821	0016744780

Patients

Seq	Age	Sex	Outcome	Treatment
1