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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
Event Date 04/20/2017
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. (b)(4).

 
Event Description

It was reported that the catheter was unable to pace during use. Pacing was achieved intermittently. The catheter was replaced and the problem was solved. Inquired of patient demographics. Unable to be obtained. Further details could not be obtained. There were no patient complications reported.

 
Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1. 3 cc limited volume syringe at gate valve was returned for evaluation. A non-edwards 5fr introducer was seated between 44 cm and 58 cm from the catheter tip. The catheter body was tied with attached strings at approximately 32 cm, 44 cm and 50 cm proximal from the catheter tip. Clotted blood was observed from the catheter and introducer. No visible damage or abnormality to the balloon, windings or returned syringe was observed. Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed. The balloon inflated clear and concentric with 1. 3 cc air and the balloon remained inflated for 5 minutes without leakage. Balloon inflation testing was performed using returned syringe with 1. 3 cc air by holding the balloon under water for 5 minutes. Visual examinations were performed under microscope at 20x magnification and with the unaided eyes. Customer report of pacing issue could not be confirmed during the analysis, as the device responded appropriately during functional testing. There was no evidence of a manufacturing nonconformance. No further actions will be taken at this time. 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.

 
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Brand NameSWAN-GANZ BIPOLAR PACING CATHETER FOR SVC 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
Manufacturer Contact
lynn selawski
1 edwards way
irvine , CA 92614
9497564386
MDR Report Key6564314
Report Number2015691-2017-01307
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/03/2018
Device MODEL NumberPE074F5
Device LOT Number60615078
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/10/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2016
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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