FDA Adverse Event Malfunction Summary report: N

CAPTIFLEX¿

MDR report key: 2882344 · Received December 20, 2012

Report

Report Number: 3005099803-2012-06214
Event Type: Malfunction
Date Received: December 20, 2012
Date of Event: October 15, 2012
Report Date: December 14, 2012
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Product Code: FDI
PMA / PMN Number: K941750
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) FOR THE INVESTIGATION FINDINGS: FLARE DETACHED. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE SHEATH TO BE KINKED. ADDITIONALLY, THE FLARE WAS DETACHED. THE CONDITION OF THE DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT WAS CONFIRMED. MANIPULATION OF THE DEVICE DURING THE PROCEDURE LIKELY PRODUCED THE KINK FOUND IN THE WORKING LENGTH, WHICH WOULD CREATE RESISTANCE DURING SUBSEQUENT ATTEMPTS TO ACTUATE THE DEVICE. THIS RESISTANCE CAN ULTIMATELY CAUSE THE FLARE TO DETACH, THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE DEFECTS IDENTIFIED IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO OPEN THE SNARE, THE SNARE LOOP WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED USING A SECOND CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPTIFLEX¿	SMALL OVAL - FLEXIBLE	FDI	BOSTON SCIENTIFIC - COSTA RICA (COYOL)	M00562422	15238409

Patients

Seq	Age	Sex	Outcome	Treatment
1