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

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).

• Brand Name: CHANDLER TRANSLUMINAL V-PACING PROBE
• Type of Device: CHANDLER 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 Key: 6709236
• Report Number: 2015691-2017-02030
• Device Sequence Number: 1
• Product Code: LDF
• 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 Received: 07/12/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/23/2019
• Device MODEL Number: D97130F5
• Device Catalogue Number: D98100
• Device LOT Number: 60789579
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/27/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial