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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 (1439)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2019
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 swan ganz catheter was unable to pace from the beginning of use.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.
 
Manufacturer Narrative
Reference capa-20-00141.
 
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Brand Name
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
Type of Device
PACING CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco PR 00610
MDR Report Key8745355
MDR Text Key149670715
Report Number2015691-2019-02368
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
PMA/PMN Number
K813521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/06/2020
Device Model NumberPE074F5
Device Lot Number61719570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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