FDA Adverse Event Malfunction Summary report: N

SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)

MDR report key: 3912996 · Received July 3, 2014

Report

Report Number: 2015691-2014-01524
Event Type: Malfunction
Date Received: July 3, 2014
Date of Event: May 6, 2014
Report Date: May 7, 2014
Manufacturer: EDWARDS LIFESCIENCES, PR
Product Code: DYG
PMA / PMN Number: K822723
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CATHETER THAT WAS RETURNED FOR EVALUATION HAD A RUPTURED BALLOON WITH LATEX MATERIAL MISSING. ONE PACING CATHETER WITH ATTACHED MONOJECT 1.3 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. THE BALLOON WAS FOUND TO BE RUPTURED AROUND THE CIRCUMFERENCE AT THE CENTRAL AREA OF THE BALLOON LATEX. THE RUPTURED EDGES OF THE LATEX DID NOT APPEAR TO MATCH UP, INDICATING A GAP OF MISSING LATEX. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE TO THE CATHETER BODY OR SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.3 CC AIR. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT OF BALLOON RUPTURE WAS CONFIRMED DURING THE EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

Description of Event or Problem · 1

IT WAS REPORTED THAT "THE BALLOON GOT RUPTURED AT THE INFLATION TEST BEFORE USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
390849	SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)	PACING CATHETER	DYG	EDWARDS LIFESCIENCES, PR	D97130F5

Patients

Seq	Age	Sex	Outcome	Treatment
1