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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)

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EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION) Back to Search Results
Model Number PEK074F5
Device Problem Pacing Problem
Event Date 04/27/2018
Event Type  Malfunction  
Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1. 3 cc limited volume syringe was returned for evaluation. Visual examination found that the catheter body and the distal lead wire were broken off at approximately 34. 5 cm proximal from the catheter tip. Cross surface of broken catheter body appeared uneven and rough. Both broken edges appeared to have the same shape. Continuity testing confirmed the distal circuit was continuous from the broken lead wire to the distal electrode and from the broken lead wire to the distal connector pin. The proximal circuit was found to be continuous. Visual examinations were performed under microscope at 20x magnification and with the unaided eyes. A device history record review was completed and documented that device met all specifications upon distribution. Customer report of pacing issue was confirmed during the evaluation. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. 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. After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration. Care should be taken not to kink the catheter body when securing it. 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.

 
Event Description

It was reported that the catheter was unable to pace from the beginning of use. The cable was exchanged but the problem was not solved. The catheter was replaced and the problem was solved. 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 AND KIT (FOR SUPERIOR VENA CAVA 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
saantha eveleigh
1 edwards way
irvine , CA 92614
9492503939
MDR Report Key7526425
Report Number2015691-2018-01885
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPEK074F5
Device LOT Number61176165
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/08/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2017
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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