MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 15 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number	990063-015
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 990063-015 mapping catheter with lot number 228436369 was returned and analyzed.Visual inspection of the mapping catheter was performed.The loop segment area showed the loop was intact with no apparent issues.No damage was observed along with the tip/loop section of the mapping catheter.The pebax tubing was intact with no apparent issues.No damage was observed along with the pebax tubing section of the mapping catheter.The electrodes were intact with no apparent issues.All electrodes existed on the loop section and no cosmetic issue or anomalies were identified.The shaft was kinked approximately 2.4 inches from the lemo connector.The introducer was intact with no apparent issues.No damage or any other issue was observed along with the introducer.The inserter was detached from lemo connector.The functional test was performed using a multimeter and the mapping catheter was connected to the test cable.The continuity and impedance measurement between electrodes and the other side of the cable showed the electrocardiogram (ecg) electrode one to pin one was an open circuit.The rest of the channels were normal.Dissection of the suspect ed electrode related to the noise, revealed the electrode wire was broken from the welding at electrode one.In conclusion the mapping catheter failed the returned product inspection due to a broken electrode wire at the weld, a kink/twist on the catheter shaft, and the connector insert was detached from the lemo connector.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 from the mapping catheter.The mapping catheter was replaced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE MAPPING CATHETER - 15 MM
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20417751
• Report Number: 9617601-2024-00236
• Device Sequence Number: 12812706
• Product Code: DRF
• UDI-Device Identifier: 00643169467378
• UDI-Public: 00643169467378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102588
• 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
• Report Date (Section B): 10/10/2024

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: 03/14/2026
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 228436369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 70 KG