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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 12/01/2016
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 the catheter was unable to pace from the beginning of use. The catheter was replaced and the problem was solved. Implantation of a pacemaker was planned for the patient. Further detail could not be obtained. There were no patient complications reported. Patient demographic information requested but unavailable.

 
Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1. 3 cc limited volume syringe was returned for evaluation. No visible damage to the balloon, windings or returned syringe was observed. Continuity testing confirmed a full open condition of the proximal circuit. The distal circuit was found to be continuous. A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing lead wires. The proximal lead wire was found to be broken around the solder joint. The balloon inflated clear and concentric with 1. 3 cc air and the balloon remained inflated for 5 minutes without leakage. Balloon inflation testing 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. 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. 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. 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.

 
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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
one edwards way
irvine , CA 00610
9497564386
MDR Report Key6187729
Report Number2015691-2016-03809
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/04/2018
Device MODEL NumberPE075F5
Device LOT Number60359458
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/05/2016
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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