MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, abnormalities in the mapping catheter leads caused the physician to withdraw the mapping catheter.Abnormalities on the loop were noted, and the mapping catheter was replaced to resolve the issue.It was noted detachment from the outer material layer of the mapping catheter occurred.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: 220189045 was returned and analyzed.Visual inspection of the loop area was performed and identified displaced electrodes, loop damage, and the inserter was stuck at the achieve loop.In conclusion, the reported mapping catheter lead / loop / detachment issue was confirmed through testing and failed inspection due to loop damage and electrode displacement.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.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• MDR Report Key: 10822532
• MDR Text Key: 215939967
• Report Number: 9617601-2020-00014
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: 06/16/2022
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 220189045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/29/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1