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

Model Number	2ACH25
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9633646
• Report Number: 9612164-2020-00429
• Device Sequence Number: 16777894
• Product Code: DRF
• UDI-Device Identifier: 00643169591004
• UDI-Public: 00643169591004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1