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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2022

Event Type  Death  

Event Description

Literature was reviewed regarding circumferential pulmonary vein isolation (cpvi).The authors described one patient death.The patient died suddenly of unknown causes three weeks post procedure.There is no allegation of device-death relatedness indicated in the article; however, the cause of death and device-relatedness has been requested, but not yet received.The status of the catheters is unknown.No additional adverse patient effects were reported.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/69 years old.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: bailout left atrial appendage occluder for pulmonary vein isolation and electrical cardioversion in patients with atrial fibrillation and left atrial appendage thrombus: a pilot study.Clinical research in cardiology.2023.112:772¿783 doi: 10.1007/s00392-022-02085-0 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19112211
• MDR Text Key: 340222478
• Report Number: 9617601-2024-00060
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• 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 Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Male