MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number CA190RC1

Device Problems Device Alarm System (1012); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  Injury  

Event Description

According to the reporter, during an ablation procedure, temperature alarm activated at the antenna connection (electronic and water cooling set), when already positioned in the patient, even after antenna was changed, and cooling system was checked, there was no effect from reset button. the two antennas have been opened and used, and the reusable cable seemed to be the cause of the failure.The procedure was cancelled and the patient was already under anesthesia.

Manufacturer Narrative

D10 concomitant product: ca20l2 - ca20l2 20cm rein percutaneous antenna x1, lot# 22lg021; ca20l2 - ca20l2 20cm rein percutaneous antenna x1, s22lg015.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: EMPRINT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19027056
• MDR Text Key: 339217485
• Report Number: 3004962788-2024-00018
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521190764
• UDI-Public: 10884521190764
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA190RC1
• Device Catalogue Number: CA190RC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other