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 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot number 0009990642 was returned and analyzed.Visual inspection of the sheath showed a kink 2.625 inches from the tip.The deflection worked as per specification.It was noted there could be steering difficulty due to a kink on the shaft.In conclusion, the sheath failed the returned product inspection due to a shaft kink.If information is provided in the future, a supplemental report will be issued.

Event Description

After a completed case, the sheath tested out of specification per the manufacturer's investigation.

• 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: 10920733
• MDR Text Key: 218723998
• Report Number: 3002648230-2020-00621
• Device Sequence Number: 1
• Product Code: DRA
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009990642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• 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 Age: 72 YR