FDA Adverse Event Malfunction Summary report: N

FOGARTY ARTERIAL EMBOLECTOMY CATHETER

MDR report key: 3883459 · Received June 19, 2014

Report

Report Number: 2015691-2014-01405
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 7, 2014
Report Date: May 7, 2014
Manufacturer: EDWARDS LIFESCIENCES PR
Product Code: DXE
PMA / PMN Number: PREAMENDMENT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

WE RECEIVED ONE 120404F EMBOLECTOMY CATHETER FOR EXAMINATION. EXAMINATION OF THE CATHETER FOUND THE CATHETER TO BE BROKEN IN HALF PROXIMAL OF THE CATHETER TIP. THE PROXIMAL WINDINGS WERE FOUND TO HAVE SLIPPED DISTAL ON THE CATHETER TIP TRAPPING THE INFLATION MEDIA INSIDE THE BALLOON. THE BALLOON DID NOT RUPTURE. THIS CONDITION MAY OCCUR WHEN THE PULL FORCE OF 1.5 LBS ON THE INFLATED BALLOON (PER IFU) HAS BEEN EXCEEDED. THE DISTAL WINDINGS APPEAR TO BE IN GOOD CONDITION AND THERE ARE NO MISSING COMPONENTS. THE CATHETER BODY WAS MEASURED AND FOUND TO BE 4MM LONGER BETWEEN THE CATHETER TIP AND THE 10CM MARKER. THOUGH WE HAVE CONFIRMED PRODUCT DAMAGE EXISTS, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. NO ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING USE THE BALLOON BURST/RUPTURED WHILE INSIDE THE PATIENT. THE CUSTOMER STATED THAT THE BALLOON WAS STILL ATTACHED AT ONE END AND NO MISSING LATEX WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361085	FOGARTY ARTERIAL EMBOLECTOMY CATHETER	CATHETER, EMBOLECTOMY	DXE	EDWARDS LIFESCIENCES PR	120404F	59675691

Patients

Seq	Age	Sex	Outcome	Treatment
1