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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 06/26/2017
Event Type  Malfunction  
Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product, 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. (b)(4).

 
Event Description

It was reported that the catheter was unable to pace during use. No further information could be obtained. Patient demographic information requested but unavailable. There were no patient complications reported.

 
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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
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 Key6709022
Report Number2015691-2017-02026
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/02/2019
Device MODEL NumberPE074F5
Device LOT Number60738077
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/06/2017
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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