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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 (1439)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
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.

 
Event Description

It was reported that the swan ganz catheter was unable to pace from the beginning of use after catheter insertion. The catheter was exchanged and the problem was solved. It is unknown if the patient had cardiac conduction defect. Patient demographic information requested but unavailable. 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
jessica atallah
1 edwards way
irvine, CA 92614
9492500249
MDR Report Key9324123
MDR Text Key194618355
Report Number2015691-2019-04235
Device Sequence Number1
Product Code LDF
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK813521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPE075F5
Device LOT Number62331519
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2019
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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