MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH ADVANCE; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

While undergoing a pv cryoablation procedure frost was noted on the introducer sheath and md could not advance or reposition the system, which appeared to be internally frozen.Entire system was replaced for the procedure.

• Brand Name: FLEXCATH ADVANCE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC, INC.; kristyn benson; 8200 coral sea street; mounds view MN 55112
• MDR Report Key: 6964834
• MDR Text Key: 89829775
• Report Number: 6964834
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 61044
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 54 YR