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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR CHANDLER TRANSLUMINAL V-PACING PROBE CHANDLER PACING PROBE

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EDWARDS LIFESCIENCES PR CHANDLER TRANSLUMINAL V-PACING PROBE CHANDLER PACING PROBE Back to Search Results
Model Number D97130F5
Device Problem Pacing Problem
Event Date 06/24/2017
Event Type  Malfunction  
Manufacturer Narrative

The product is expected to be returned, but has not yet been received. Upon receipt and evaluation of the device a supplemental report will be submitted with the investigation findings. The correct lot number was not provided; therefore, a review of the manufacturing records could not be completed. 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. (b)(4).

 
Event Description

It was reported that during use the pacing wire was unable to capture and no paced beats were seen. The test cable and pacer box were changed, but the problem persisted. The pacing catheter was then changed and the problem was solved. No patient injury.

 
Manufacturer Narrative

Our product evaluation laboratory received one swan ganz pacing catheter. The proximal circuit was found to be open. The proximal lead wire was found to be broken approximately 2. 5cm proximal of the distal tip. Insulation was not present on the lead wires at the location of damage. The distal electrode circuit was found to be continuous. The catheter body was found to be in good condition. The balloon inflated clear and concentric and did not leak. A device history record review was completed and documented that the device met all specifications upon distribution. Report of "defective pacing wire" was confirmed. An engineering evaluation task was initiated to assess manufacturing-related processes which could be correlated to the complaint. 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. Correction upon receipt of the device by the product evaluation laboratory, the model number was confirmed to be d97130f5 not d98100. The correct lot number, 60789579, was supplied by the customer, but the model number was incorrect. It was confirmed that the lot number was correct after confirmation of the correct model number was received. Udi number is (b)(4).

 
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Brand NameCHANDLER TRANSLUMINAL V-PACING PROBE
Type of DeviceCHANDLER PACING PROBE
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
brian hurd-servin
1 edwards way
irvine , CA 92614
9492506423
MDR Report Key6709236
Report Number2015691-2017-02030
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/23/2019
Device MODEL NumberD97130F5
Device Catalogue NumberD98100
Device LOT Number60789579
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2017
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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