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 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The 4fc12 sheath with lot number 0010396178 was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked at four locations.It was noted the sheath was likely kinked during shipment.A balloon test catheter under vacuum and with the push button in the forward position failed the insertion into the returned sheath at the kink locations.The afapro28 balloon catheter with lot number 13102 also failed the insertion into the returned sheath at the kink locations.In conclusion, the sheath failed the returned product inspection due to shaft kinks.If information is provided in the future, a supplemental report will be issued.

Event Description

The sheath subsequently tested out of specification per the manufacturers 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: 11226061
• MDR Text Key: 241236674
• Report Number: 3002648230-2021-00038
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010396178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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