MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER THAT IS USED WITH THE MEDTRONIC CRYOABLATION SY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 2ACH20

Patient Problem Insufficient Information (4580)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Tip of medtronic achieve catheter broke off in the right superior pulmonary vein.Provider was pulling the medtronic balloon out when the tip broke off.Provider used a snare to retrieve the achieve catheter.All device was removed intact.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER THAT IS USED WITH THE MEDTRONIC CRYOABLATION SY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 18686112
• MDR Text Key: 335246905
• Report Number: MW5151348
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 02/07/2024

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 Model Number: 2ACH20
• Device Lot Number: 8779916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1