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

Model Number 990063-020

Device Problem Kinked (1339)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed 12 injections were performed with a balloon catheter on the date of the event without triggering of any system notice.Visual inspection of the mapping catheter showed loop kink.The mapping catheter was connected to the diagnostic computer and channel pairs did not display any noise.Movement and deflection of the catheter distal to the lemo connector did not induce any interference noise.In conclusion, the reported noise issue was not confirmed through data analysis or testing.The mapping catheter failed the return inspection due to a loop kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, noise was observed on the mapping catheter.The mapping catheter was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.The device was returned to the manufacturer, analyzed, and 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: 7635950
• MDR Text Key: 112285827
• Report Number: 9612164-2018-01535
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2018

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: 11/16/2019
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 214246274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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