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 Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

After a completed case, the mapping catheter subsequently tested out of specification per the manufacturer's investigation.

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 224107504 was returned and analyzed.Visual inspection of the loop segment area was performed.It showed:the loop was completely damaged, the loop shape was deformed and out of plane, the loop was kinked and ribbed all over its section, and the loop was torn and damaged.Visual inspection of the pebax segment area showed the pebax tubing was ribbed and damaged.Visual inspection of the electrodes showed the five remaining electrodes were displaced from its original location.There were three electrodes found detached from the pebax tubing and were not returned with the device.In conclusion, the mapping catheter failed the returned product inspection due to a detached electrode/loop condition observed at the loop segment, a kink observed at the tip/loop of the pebax tubing, a displaced electrode observed on the loop of the pebax tubing, a detached electrode wire observed at the weld, a tear observed at the tip/loop of the pebax tubing, and a pinch observed at the tip/lo op 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.

• 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: 15549986
• MDR Text Key: 306840844
• Report Number: 9617601-2022-00132
• Device Sequence Number: 1
• Product Code: DRF
• 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: 10/06/2022

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 Expiration Date: 04/07/2024
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 224107504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2022
• 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