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.

• 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
• 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