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

Device Problems Signal Artifact/Noise (1036); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 227872383 was returned and analyzed.Visual inspection of the loop segment area showed that the loop was kinked/twisted near the electrodes eight and six.Visual inspection of the pebax segment area showed that the pebax tubing was ribbed at approximately 0.5 inches from the loop distal tip.Visual inspection of the introducer showed that the introducer/ loop straightener was removed from the returned mapping catheter and was unable to be re-inserted due to the curvature of the mapping catheter's distal loop.The functional test was performed using a multimeter and the mapping catheter was connected to the test cable.The continuity and impedance measurement between the electrodes and the other side of the cable showed the electrodes' continuity and impedance to the cable were as expected.In conclusion, the reported electrocardiogram (ecg) signal issue was not observed/reproduced.The mapping catheter failed the returned product inspection due to a kink observed at the tip/loop of the pebax tubing, a ribbed material observed on the pebax tubing, and the introducer being removed from the mapping 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 Description

It was reported that during a cryo ablation procedure, the mapping catheter was unable to track the signals.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 - 20 MM
• Type of Device: 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: 19098703
• MDR Text Key: 340807571
• Report Number: 9617601-2024-00056
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 227872383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1