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

Model Number 2ACH20

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

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the balloon was deflated.The coaxial umbilical cable was reconnected a system test and inflation was carried out but the issue did not resolve.The coaxial umbilical cable was replaced.The balloon catheter was replaced to resolve the issue.Afterwards there was noise displayed on the mapping catheter's potential. the mapping catheter cable was replaced without resolve.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.

Manufacturer Narrative

Product event summary: the 2ach20 mapping catheter with lot number 7098277 was returned and analyzed.Visual inspection of 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.Visual inspection of 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.Visual inspection of the shaft segment area showed the shaft was kinked approximately 56 inches from the lemo connector.Visual inspection of the introducer showed the introducer was intact with no apparent issues.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.Pin to pin continuity test failed due to an open circuit at electrode #7.The electrode-wire connection on the loop section was as expected.No wires were detached from lemo.Dissection of the lemo connector assembly revealed kinked electrical wire inside the lemo connector.Plausibly, the kink could have caused the open circuit.In conclusion, the mapping catheter failed the returned product inspection due to the shaft kink.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.If information is provided in the future, a supplemental report will be issued.

• 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: 16478492
• MDR Text Key: 310873769
• Report Number: 2182208-2023-00606
• Device Sequence Number: 1
• Product Code: DRF
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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: 7098277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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