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

Model Number 4FC12

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

The sheath subsequently tested out of specification per the manufacturer's investigation.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot 0010805965 was returned and analyzed.Visual inspection was performed on the shaft identified a shaft kink/twist at approximately 2.44 inches from the tip.Functional testing of the steering mechanism and a deflection test were performed.The shaft would bend as initially intended and would bend in the plane.There was no difficulty, no friction, or any noise in the steering mechanism.In conclusion, the sheath failed the returned product inspection due to a kink/twist that was observed on the shaft.If information is provided in the future, a supplemental report will be issued.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13446987
• MDR Text Key: 288696573
• Report Number: 3002648230-2022-00051
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010805965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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