MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

Model Number D97120F5

Device Problems Kinked (1339); No Pacing (3268)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

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 34cm and 39cm proximal from the catheter tip and waved between approximately 4 cm and 90 cm proximal from the catheter tip.The catheter body was tied by attached string at 6cm proximal from the catheter tip.A non-edwards introducer was seated to the catheter between approximately 76.5 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 confirmed a full open condition of the distal and proximal circuits, respectively.The catheter body was kinked and partially cut at approximately 63.5 cm from the catheter tip.The balloon did not inflate due to leakage from the cut at 63.5 cm proximal from the catheter tip.The catheter body was kinked at approximately 69 cm and 90 cm proximal from the catheter tip.A cut down of the catheter body was performed just proximal of the proximal electrode and just distal of the y-adapter to expose the pacing lead wires.The lead wires were found to be broken at approximately 69 cm from the catheter tip where the catheter body was kinked.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.Per ifu, ¿the incidence of complications increases significantly with indwelling periods longer than 72 hours." the lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 pacing failure was observed on the fifth day of use when the permanent pacemaker was implanted.After implantation, the pacing catheter was removed.There was a kink noted on the catheter.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)
• 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 ; 9497564386
• MDR Report Key: 5490405
• MDR Text Key: 40356052
• Report Number: 2015691-2016-00729
• 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: 03/09/2016
• 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: 02/18/2016
• 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