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	Mechanical Problem (1384); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: afapro28, product type: balloon catheter 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, a system notice was received indicating that the system did not recognize the catheter.The balloon catheter was replaced to resolve the issue. it was also reported that the mapping catheter was damaged and the loop was "not true" and unable to hold its shape after exiting the sheath.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.
Additional Manufacturer Narrative
Product event summary: the 990063-015 mapping catheter with lot 227669016 was returned and analyzed.Visual inspection was performed, and a kink was observed at the tip/loop of the tubing.Additionally, bond damage was observed at the shaft to the tube fitting, and a pinch was observed at the tip/loop of the tubing.Visual inspection of the loop segment area showed the loop was kinked/twisted near the tip, and the loop was pinched near the electrode six.Visual inspection of the pebax segment area showed the pebax tubing at the shaft fitting joint was damaged/kinked.Visual inspection of the electrode(s) showed the electrode(s) were intact with no apparent issues.All electrodes exist on the loop section and no cosmetic issues or anomalies were identified.Visual inspection of shaft segment area showed the shaft was intact with no apparent issues and no kink or any other damage was observed along with the shaft of the mapping catheter.Visual inspection of the introducer showed the introducer was intact with no apparent issues, and no damage or any other issue was observed along with the introducer.Visual inspection of the lemo connector showed the lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.In conclusion, the mapping catheter failed the returned product inspection due to a tip/loop kink, shaft bond damage, and a pinch at the tip/loop of the 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 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: 18952215
• Report Number: 9617601-2024-00039
• Device Sequence Number: 20846003
• Product Code: DRF
• UDI-Device Identifier: 00643169467378
• UDI-Public: 00643169467378
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/01/2024

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: 11/21/2025
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 227669016
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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 Sex: Unknown