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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION Back to Search Results
Model Number PE075F5
Device Problem Pacing Problem
Event Date 06/07/2018
Event Type  Malfunction  
Manufacturer Narrative

One bipolar pacing catheter with detached monoject 1. 3 cc limited volume syringe was returned for evaluation. Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed. The balloon inflated clear and concentric with 1. 3 cc air and the balloon remained inflated for 5 minutes without leakage. No visible damage or abnormality to the catheter body, balloon, windings or returned syringe was observed. Balloon inflation testing 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. Customer report of pacing issue could not be confirmed during the analysis, as the device responded appropriately during functional testing. There was no evidence of a manufacturing nonconformance. No further actions will be taken at this time. Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients. There are multiple failure modes that may require the exchange of a pacing catheter. Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter. Stretching, kinking, or forceful wiping of the catheter may result in damage. After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration. Care should be taken not to kink the catheter body when securing it. In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported 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 catheter was exchanged and the problem was solved. Patient demographic information requested but unavailable. No further information could be obtained. There were no patient complications reported.

 
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Brand NameSWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
Type of DevicePACING 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 Key7642508
Report Number2015691-2018-02481
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPE075F5
Device LOT Number61288496
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/14/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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