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); Compatibility Problem (2960); Material Twisted/Bent (2981)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 225151080 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 segment area showed pebax tubing was kinked/twisted at approximately 2.71 inches from loop distal tip.The user may have experienced insertion difficulties due to this issue when introducing the mapping catheter into the balloon catheter.Visual inspection of the electrodes showed the electrodes were intact with no apparent issues.All electrodes exist on the loop section and no cosmetic issue or anomalies were identified.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.Pin to pin continuity test failed due to an open circuit at electrodes # 4,#5 ,#6,#7,#8.Due to this, the user may have experienced interference issues.Dissection of the suspected electrode related to the noise revealed the electrode wires were broken from the welding at electrodes 4, 5, 6 ,7, 8.In conclusion, the mapping catheter failed the returned product inspection due to the tip/loop 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.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, there was resistance felt when the mapping catheter was brought back into the sheath.The signal was then lost.The mapping catheter was adjusted without resolve.The mapping catheter was moved around the heart and signal was further lost.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.

• 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: 16613498
• MDR Text Key: 312409523
• Report Number: 9617601-2023-00055
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169467385
• UDI-Public: 00643169467385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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: 225151080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female