FDA Adverse Event Malfunction Summary report: N

FOGARTY ARTERIAL EMBOLECTOMY CATHETER

MDR report key: 2992740 · Received March 7, 2013

Report

Report Number: 2015691-2013-19471
Event Type: Malfunction
Date Received: March 7, 2013
Date of Event: February 14, 2013
Report Date: February 14, 2013
Manufacturer: EDWARDS LIFESCIENCES, PR
Product Code: DXE
PMA / PMN Number: PREAMENDMENT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CATHETER WAS RECEIVED IN A BROKEN GRAY SHIPPING TUBE. THE EVALUATION INCLUDED VISUAL EXAMINATION, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE GRAY SHIPPING TUBE WAS BROKEN 19CM DISTAL OF THE CLEAR ADAPTOR. THE SHRINK SEALS WERE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THERE WAS NO OUTER BOX RECEIVED WITH THE PRODUCT. THE CATHETER BODY WAS FOUND BENT AT THE BREAK SITE OF THE SHIPPING TUBE; HOWEVER, THE CATHETER ITSELF WAS NOT BROKEN, AS ORIGINALLY REPORTED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. A BROKEN SHIPPING TUBE WAS CONFIRMED AND APPEARS TO BE RELATED TO SHIPPING OF THE PRODUCT. AN INVESTIGATION IS CURRENTLY UNDERWAY TO DETERMINE THE VARIABLES THAT CAN IMPACT THE PRODUCT DURING SHIPPING, IN AN EFFORT TO REDUCE COMPLAINTS OF THIS TYPE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE 2 CATHETERS WERE RECEIVED DAMAGED. THE TWO CATHETERS WERE BROKEN IN HALF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
97381	FOGARTY ARTERIAL EMBOLECTOMY CATHETER	CATHETER, EMBOLECTOMY	DXE	EDWARDS LIFESCIENCES, PR	120804F	59397322

Patients

Seq	Age	Sex	Outcome	Treatment
1