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 Entrapment of Device (1212); Mechanical Problem (1384); Material Integrity Problem (2978); Device Handling Problem (3265)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that cryo ablation procedure, the mapping catheter was stuck in the left superior pulmonary vein (lspv) and could not be retracted into the balloon catheter.The sheath was advanced over the system to retrieve the mapping catheter.After the catheter was removed, it was reported that the tip of the catheter was damaged.The mapping catheter was replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Manufacturer Narrative

Product event summary: four image files and the 990063-020 mapping catheter with lot number 227846032 were returned and analyzed.The first image showed a suspicious tissue attached to the mapping catheter loop inside of the patient under x-ray imaging.The second, third, and fourth images showed the mapping catheter pebax loop ribbed between electrodes five and eight.Visual inspection of the mapping catheter showed that the loop was kinked and ribbed near electrodes one to eight.Visual inspection of the pebax tubing area showed the pebax tubing was intact with no apparent issues or damage.Visual inspection of the electrodes showed that electrodes one to eight were displaced from their original locations.Visual inspection of shaft segment area showed the shaft was intact with no apparent issues.No kink or any other damage was observed along with the shaft.Visual inspection of the introducer showed the introducer was intact with no apparent issues or damage.Visual inspection of the lemo connector showed the lemo connector was intact with no apparent issues or damage.Functional testing was unable to be performed due to the condition of the mapping catheter.In conclusion, the reported issue of mapping catheter tip damage was confirmed through testing and the entrapment issue occurred during the procedure.The mapping catheter failed the returned product inspection due to a displaced electrode obse rved on the loop of the pebax tubing, a kink observed at the tip/loop of the pebax tubing, and a pinch observed at the tip/loop 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: 18677965
• MDR Text Key: 336303263
• Report Number: 9617601-2024-00018
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 227846032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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