MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number	990063-020
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
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, when prepping the mapping catheter there was difficulty inserting the mapping catheter into the co-pilot.The mapping catheter was noted to be kinked on the proximal end of the shaft.The mapping catheter was replaced to resolve the issue. 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 990063-020 mapping catheter with lot number 227844603 was returned and analyzed.Visual inspection 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 area showed 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 11.75 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 lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.The mapping catheter was connected to the test cable and the continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's continuity and impedance to the cable were normal.In conclusion, the reported kink issue was confirmed through analysis and the mapping catheter failed the returned product inspection due to a kink/twist on the catheter shaft.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 MAPPING CATHETER - 20 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: 19141645
• Report Number: 9617601-2024-00064
• Device Sequence Number: 7960335
• Product Code: DRF
• UDI-Device Identifier: 00643169467385
• UDI-Public: 00643169467385
• 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,Followup
• Report Date (Section B): 08/07/2024

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: 12/02/2025
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 227844603
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2023
• 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: 79 YR
• Patient Sex: Female