MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: x-ray inspection of the guide wire lumen showed what appeared to be a fragment from the pebax shaft of the mapping catheter (b)(4).X-ray confirmed all the electrodes (eight of them) were entrapped along the guide wire lumen of the balloon catheter.Visual inspection of the mapping catheter showed the distal part of the loop was absent including all the electrodes, pebax covering in the array section appeared twisted and ribbed.A product performance test was unable to be performed due to the catheter being received damaged.All the electrodes were retrieved entrapped within guide wire lumen of the associated balloon catheter.In conclusion, the reported damaged mapping catheter has been confirmed through inspection.The mapping catheter failed visual inspection due to damaged tip/loop section.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an out of specification finding was discovered, following analysis of the mapping catheter.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was an unknown complaint during a cryo procedure.The case was completed with cryo.No patient complications have been reported as a result of this event.Upon analysis of the product and return, both the balloon catheter and the mapping catheter tested out of specification.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7245021
• MDR Text Key: 99241011
• Report Number: 9612164-2018-00211
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 213342405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1