MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION); DYG

Model Number D97130F5

Device Problem No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.Continuity testing found that a short condition occurred between the proximal and distal circuits.No open or short condition was observed in the leadwires between the distal y-adaptor and the electrodes.Some indentations were observed from the connectors.No other visible damage was observed from the catheter body, balloon, windings, or returned syringe.The balloon inflated clear and concentric and remained inflated for 5minutes without leakage.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examination was 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.Customer report of pacing issue was confirmed during the evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Swan-ganz bipolar pacing catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.All invasive procedures inherently involve some patient risks.The physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are described in the literature.Cases of myocardial perforation associated with the use of temporary trans-venous pacing catheters have been reported.Careful repositioning and withdrawal of the catheter under fluoroscopic control is recommended.It is unknown if user or procedural factors may have contributed to this event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that the swan ganz catheter was unable to pace from the beginning of use.The batteries of the pacemaker were changed and the cable was replaced but the problem was not solved.It is unknown if the patient had cardiac conduction defect or what kind of surgery/examination the catheter was used.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Further testing was conducted by product evaluation lab.A cut down was performed at the catheter tip and y-adaptor.Insulation of the distal leadwire in the catheter tip was found to be damaged.Short condition between the leadwires was observed at the catheter tip when the leadwires were in contact.No visible abnormality was observed from the leadwires in the y-adaptor.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 FEMORAL INSERTION)
• Type of Device: DYG
• Manufacturer (Section D): EDWARDS LIFESCIENCES; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11304992
• MDR Text Key: 246297469
• Report Number: 2015691-2021-01190
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Device Lot Number: 63143564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1