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

Model Number	2ACH20
Medical Device Problem Codes	Signal Artifact/Noise (1036); Compatibility Problem (2960); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a cryo ablation procedure, there was noise on electrodes one, two, and three.It was then reported that when retracting the mapping catheter into the balloon catheter, there was resistance.Additionally, after the mapping catheter was removed from the patient, it was observed that the loop was kinked.The mapping catheter was replaced which resolved the issues.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 2ach20 mapping catheter with lot number 8865206 was returned and analyzed.Visual inspection of the loop segment area showed the loop was kinked/twisted near the electrode four.Visual inspection of the pebax tubing area showed it was intact with no apparent issues or damage observed.Visual inspection of the electrode showed the electrode was intact with no apparent issues.All electrodes existed on the loop section and no cosmetic issue or anomalies were identified.Visual inspection of shaft segment area showed it was intact with no apparent issues, kink, or any other damage observed.Visual inspection of the introducer showed the introducer was intact with no apparent issues or damage.Visual inspection of the lemo connector showed it was intact with no apparent issues or damage.The functional test was performed using a multimeter and the mapping catheter connected to the test cable.The continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's conti nuity and impedance to the cable were normal.In conclusion, the reported issue of a tip/loop kink was confirmed through analysis.The mapping catheter did not pass the returned product inspection due to a kink observed at the tip/loop of the pebax tubing.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19962530
• Report Number: 2182208-2024-03312
• Device Sequence Number: 12944548
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 03/19/2026
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 8865206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male