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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 05/15/2018
Event Type  Malfunction  
Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1. 3 cc limited volume syringe was returned for evaluation. Blood was visible inside the balloon. Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed. The balloon inflated but failed to maintain its inflation due to leakage from a gap around the circumference between the proximal electrode and catheter body. The leakage is due to an adhesive separation, and leakage is from under the proximal electrode. No visible damage was observed from the balloon, windings or returned syringe. 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 could not be confirmed during the analysis, as the device responded appropriately during functional testing. However, leakage between the proximal electrode and the catheter body was found. 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 during use. The catheter was exchanged and the problem was solved. Patient demographic information requested but unavailable. No further information could be obtained. There were no patient complications reported.

 
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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 00610
Manufacturer Contact
lynn selawski
1 edwards way
irvine , CA 92614
9497564386
MDR Report Key7583157
Report Number2015691-2018-02210
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPE074F5
Device LOT Number61272964
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/14/2018
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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