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

Model Number 2ACH25

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the mapping catheter 2ach25 with lot number 11157402.Visual inspection showed distal part of the loop is absent including the first, second, third and fourth electrodes.Unable to conduct performance test as the received catheter was damaged.The missing electrodes were found within the push button near the luer in the balloon catheter.The loop section could be bent.Once the mapping catheter was removed, it was stuck in the luer section of the catheter.Since the integrity of the loop was weakened because of the kink, the loop broke off.In conclusion, the reported mapping catheter bend could be confirmed since the loop section was detached.The mapping catheter failed the returned product inspection due to a damaged tip/loop section.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, the balloon catheter was removed from the sheath as the luer of the balloon catheter became loose.Additionally, the mapping catheter was physically bent.The balloon catheter and mapping catheter were replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE ADVANCE 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9633646
• MDR Text Key: 188466503
• Report Number: 9612164-2020-00429
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169591004
• UDI-Public: 00643169591004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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: 06/16/2021
• Device Model Number: 2ACH25
• Device Catalogue Number: 2ACH25
• Device Lot Number: 11157402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• 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