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 Material Twisted/Bent (2981); Device Handling Problem (3265)

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

Event Date 04/08/2024

Event Type  malfunction  

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during a cryo ablation procedure, it was difficult to position the mapping catheter into the right inferior pulmonary vein (ripv) so it was inserted into the pulmonary vein (pv) branch multiple times.Then, using fluoroscopy, it appeared the ring was kinked.The mapping catheter was retracted into the sheath and replaced with another manufacturer's electrode catheter. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 227846027 was returned and analyzed.Visual inspection of the loop showed that the loop was kinked and ribbed near the electrodes 3,4 and 6, 7.The pebax tubing was ribbed at approximately 61.5 inches from the loop distal tip.A functional test was performed using a multimeter.The mapping catheter was connected to the test cable.The continuity and impedance measurement between the electrodes and the other side of the cable were normal.An attached image showed that the tip loop appear to be kinked and twisted.In conclusion, the reported tip/loop kink was confirmed during analysis and the mapping catheter failed the returned product inspection due to a kink and ribbed material 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during a cryo ablation procedure, it was difficult to position the mapping catheter into the right inferior pulmonary vein (ripv) so it was inserted into the pulmonary vein (pv) branch multiple times.Then, using fluoroscopy, it appeared the ring was kinked.The mapping catheter was retracted into the sheath and replaced with another manufacturer's electrode catheter. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Corrected h2 and h3.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
• 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: 19187738
• MDR Text Key: 341239777
• Report Number: 9617601-2024-00071
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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: 227846027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024; 05/01/2024
• Supplement Dates FDA Received: 05/23/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• 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