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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 SVC INSERTION

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EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION Back to Search Results
Model Number PE074F5
Device Problem Pacing Problem
Event Date 02/19/2017
Event Type  Malfunction  
Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital due to infection. Without the return of the product, it is not possible to determine if damages or defects existed on the product. A device history record review was completed and documented that device met all specifications upon distribution. No 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. 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. No corrective or preventative actions are required at this time.

 
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. Further details could not be obtained. There were no patient complications reported. Inquired of patient demographics. Unable to be obtained.

 
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Brand NameSWAN-GANZ BIPOLAR PACING CATHETER FOR SVC 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 Key6411676
Report Number2015691-2017-00683
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/24/2018
Device MODEL NumberPE074F5
Device LOT Number60416558
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/02/2016
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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