MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3cc limited volume syringe was returned for evaluation.Continuity testing confirmed a full open condition of the distal circuit.The proximal circuit was found to be continuous.The catheter tip was bent and the angle was measured to be approximately 29 degrees.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.The distal leadwire was found to be broken around the solder joint.No visible damage to the balloon, windings, or returned syringe was observed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.The customer report of pacing issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Event Description

It was reported that the catheter was unable to pace after insertion during use.The catheter was replaced and the problem was solved.There were no patient complications reported.Further details could not be obtained.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5138496
• MDR Text Key: 27906335
• Report Number: 2015691-2015-02666
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: PE074F5
• Device Lot Number: 60013877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1