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 Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 02/16/2021

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, the mapping catheter was noted to be kinked at the distal transition of the shaft and loop.After removal of the mapping catheter from the body, part of the catheter broke inside the y-connector.The mapping catheter were replaced to resolve the issues.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the mapping catheter 990063-020 with lot number 220733863 was returned and analyzed.Visual inspection showed the device was kinked at 2.375 inches from the tip.Furthermore, the pebax tubing was bulged around the kink.There were two electrodes inside of the handle and one electrode on the achieve mapping catheter.As the y-connector was not returned with the other items, and the incoming information stated the mapping catheter broke inside the y-connector, it is assumed the remaining 5 electrodes are inside of the y-connector.In conclusion, the reported kink was confirmed through testing.The mapping catheter failed the returned product inspection due to a kink in the tip section, loop detachment, as well as electrode detachment.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.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, 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: 11348637
• MDR Text Key: 232551962
• Report Number: 9617601-2021-00032
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: 09/14/2022
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 220733863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1