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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 (1439)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
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 in 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 found to be broken around the solder joint. It was found that the distal circuit was continuous from broken lead wire to distal connector pin. 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 catheter body, balloon, windings, or returned syringe was found. Balloon inflation test was performed using returned syringe with 1. 3 cc air by holding the balloon under water. Visual examination was 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 analysis. 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 swan ganz catheter was unable to pace from the beginning of use. The catheter was replaced with a catheter from the same lot 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 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
lynn thomas
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key9727989
MDR Text Key192256387
Report Number2015691-2020-10590
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,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPEK074F5
Device LOT Number62132718
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/27/2019
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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