MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number 2ACH20

Device Problems Compatibility Problem (2960); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id:2af284 product type: balloon catheter.Product event summary: the 2ach20 mapping catheter of lot number 8558769 was returned and analyzed.Visual inspection was carried out.The loop was kinked and ribbed near the electrode number one.The pebax tubing area showed the pebax tubing was intact with no apparent issues.No damage was observed along 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 intact with no apparent issues.No kink or any other damage was observed along with the shaft of the mapping catheter.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 the lemo connector.The insertion compatibility inspection was performed with the test catheter and the returned mapping catheter.The mapping catheter was inserted and retracted into the balloon test catheter without any issue.In conclusion, the mapping catheter failed the returned product inspection due to a kink that was observed at the tip/loop of the pebax tubing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the mapping catheter would not advance into the balloon catheter guidewire lumen.The mapping catheter was damaged.The mapping catheter and balloon catheter were replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18603434
• MDR Text Key: 334042121
• Report Number: 2182208-2024-00309
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

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: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 8558769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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
• Treatment: SEE H10