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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
Event Date 04/18/2018
Event Type  Malfunction  
Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1. 3 cc limited volume syringe was returned for evaluation. Continuity testing confirmed a full open condition of the distal circuit. The proximal circuit was found to be continuous. A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing lead wires. The distal lead wire was able to be pulled out, and was found to be broken or not soldered at the distal electrode. Insulation appeared to remain on the distal end of the distal lead wire. The distal circuit lead wire between the cut point and the distal electrode pin was continuous. The balloon inflated clear and concentric with 1. 3 cc air and remained inflated for 5 minutes without leakage. No visible damage or defect to the balloon, windings, catheter body, or returned syringe was observed. Balloon inflation testing was performed using returned syringe with 1. 3 cc air by holding the balloon under water. 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 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 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
samantha eveleigh
1 edwards way
irvine , CA 92614
9492503939
MDR Report Key7511283
Report Number2015691-2018-01817
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPE075F5
Device LOT Number61176312
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 Received04/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/18/2017
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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