PROPLEGE CORONARY SINUS CATHETER

MDR report key: 2911418 · Received January 11, 2013

Report

Report Number: 3008500478-2013-00359
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: December 21, 2012
Report Date: February 11, 2013
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DWF
PMA / PMN Number: 5120780
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER.

Additional Manufacturer Narrative · 1

UNKNOWN LOCATION OF COMPLAINT DEVICE. REPORTING SURGEON UNEXPECTEDLY PASSED AWAY. SINCE THE DEVICE WAS NOT RETURNED, ANY MANUFACTURING DEFECT WITH THE DEVICE CANNOT BE ASSESSED. HOWEVER, IT IS LIKELY THAT THE ROOT CAUSE OF THE INTRODUCER LEAKING IS RELATED TO THE ROOT CAUSE ATTRIBUTED TO SIMILAR COMPLAINTS RECEIVED FOR THE LEAKING THAT HAVE BEEN CONFIRMED PER ASSESSMENT BY R&D AND QUALITY ENGINEERING OF THE SIMILAR COMPLAINTS WITH RETURNED DEVICES, THE ROOT CAUSE OF THE LEAKING HAS BEEN DETERMINED TO BE A MATERIAL RELAXATION ISSUE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. A CAPA HAS BEEN INITIATED FOR THESE COMPLAINTS AND PRODUCT RECALL. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem · 1

IT WAS PHONED IN BY THE SALES REP THAT UPON COMPLETION OF THE CASE THE CORONARY SINUS CATHETER, PR9 INTRODUCER WAS FOUND TO BE LEAKING, THEY APPLIED THE SLICK AND IT CONTINUED TO BACK BLEED. NO PATIENT HARM WAS REPORTED. THE DEVICE IS TO BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17571	PROPLEGE CORONARY SINUS CATHETER	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	DWF	EDWARDS LIFESCIENCES	PR9

Patients

Seq	Age	Sex	Outcome	Treatment
1