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

Model Number D97120F5

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.The catheter body was found stained yellow between 39cm and 55cm proximal from the catheter tip.The catheter body was tied by attached string at 35cm proximal from the catheter tip.A non-edwards introducer was seated to the catheter between approximately 76 cm to 90 cm proximal from the catheter tip.Blood and sticky material was observed from the catheter body and introducer.The introducer and string were removed for evaluation.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The catheter body was kinked and punctured at approximately 47 cm from the catheter tip.The balloon did not inflate due to leakage from the puncture.The catheter body was also found kinked at approximately 79.5 cm and 81 cm proximal from the catheter tip and waved between approximately 35 cm and 90 cm proximal from the catheter tip.No visible damage to the balloon or windings was observed.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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of kinked catheter was confirmed and a puncture on the catheter body was also observed.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 catheter was kinked during use.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; irvine 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 ; 9497564386
• MDR Report Key: 5505821
• MDR Text Key: 40785110
• Report Number: 2015691-2016-00810
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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