MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Compatibility Problem (2960); Material Twisted/Bent (2981)

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

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

The 4fc12 sheath with lot number 0011285098 was returned and analyzed.Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator.There was coagulated blood inside the shaft and side-tube, which was blocking the flushing during the disinfection process.Visual inspection of the shaft area was performed.The inspection identified a shaft kink/twist at approximately 2.64 inches from the tip.Test catheter insertion and retraction into the sheath were performed several times easily without any issue.In conclusion, the sheath failed the returned product inspection due to the shaft kink/twist.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, after the sheath was prepped with a competitors mapping catheter it was removed and a balloon catheter was inserted into the sheath.There was difficulty adjusting the balloon catheter and were unable to draw back from the side port.The balloon catheter was replaced without resolve.Then the sheath was exchanged to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15885483
• MDR Text Key: 307688424
• Report Number: 3002648230-2022-00474
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2022

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: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011285098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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 Sex: Male