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

Model Number PE074F5

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that a thread like material was observed on the catheter at about 5cm from the tip before use.The pouch was opened.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.As received, a white string, approximately 10 cm long, was attached to the catheter body tip with clear adhesive like material at about 8 cm from the tip.The white string material looked similar to balloon windings.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 minutes without leakage.No visible damage to the catheter body, balloon or returned syringe was observed.The thread was measured and found to be 0.0015".The catheter was cut on both sides of the adhesive like material so both the thread and adhesive material could be tested.A sample of the thread and adhesive like material was sent to chemistry for testing.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examinations were was performed under microscope at 20x magnification and with the unaided eyes.Customer report of contamination issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Manufacturer Narrative

Chemistry testing was conducted on the sample of the thread and adhesive like material removed from the catheter.The ir spectrum of the thread like material that was adhered on the catheter body showed similar absorption characteristics when compared to polyester like material.The ir spectrum of the surface of the catheter where the piece of thread was adhered on the catheter body showed similar absorption characteristics when compared to polyvinyl chloride like material.The ir spectrum of the clean surface of the catheter where a no thread was adhered showed similar absorption characteristics when compared to polyvinyl chloride like material.Further examination of the thread like material found on the catheter appears to be the thread used in the balloon winding process.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• 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 92614
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5756351
• MDR Text Key: 48401798
• Report Number: 2015691-2016-02069
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2017
• Device Model Number: PE074F5
• Device Lot Number: 60203196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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