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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER; CATHETER, FLOW DIRECTED
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EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER; CATHETER, FLOW DIRECTED Back to Search Results
Model Number D97120F5
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device involved in this complaint was not available for evaluation since it was discarded.Nevertheless, three pictures were provided for investigation.The report of catheter body issue was confirmed.Pictures showed an unknown pacing catheter next to a non-edwards introducer.Catheter body was completely broken next to proximal electrode.Leadwire was visible from catheter tip.The lot number for this device was not supplied.Therefore, the related manufacturing records were unable to be reviewed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.
 
Event Description
As reported, when removing this swan ganz pacing catheter from patient, it got stuck in the introducer.Therefore, during the maneuvers to withdraw the catheter the balloon tip detached and remained inside the introducer.There was no allegation of patient injury.Patient demographics were requested but were not available.The device was not available for evaluation.
 
Manufacturer Narrative
The device involved in this complaint was not available for evaluation since it was discarded.Nevertheless, three pictures were provided for investigation.The report of catheter body issue was confirmed.Pictures showed an unknown pacing catheter next to a non-edwards introducer.Catheter body was completely broken next to proximal electrode.Leadwire was visible from catheter tip.The lot number for this device was not supplied.Therefore, the related manufacturing records were unable to be reviewed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.
 
Event Description
As reported, when removing this swan ganz pacing catheter from patient, it got stuck in the introducer.Therefore, during the maneuvers to withdraw the catheter the balloon tip detached and remained inside the introducer.There was no allegation of patient injury.Patient demographics were requested but were not available.The device was not available for evaluation.
 
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Brand Name
SWAN-GANZ BIPOLAR PACING CATHETER
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco, puerto rico 00610
*  00610
Manufacturer (Section G)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco, puerto rico
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key13167886
MDR Text Key285186805
Report Number2015691-2022-03228
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K822723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD97120F5
Device Catalogue NumberD97120F5
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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