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

Model Number 4FC12

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot number 24627 was returned and analyzed.Visual inspection of the sheath showed that the shaft was kinked on 9 inches from the end of handle.The sheath¿s distal tip and dilator tip were intact, no fracture and breakage were noticed.No teflon delamination was noticed at the tip of the sheath¿s shaft.The sheath tip was atraumatic and with no sharp edges.The inner diameter of the tip was within specification and it provided a smooth transition to the dilator.The transition gap between the tip and the dilator was normal as seen in sheaths.Functional testing of the sheath showed that the deflection worked as per specification.In conclusion, the sheath failed the returned product inspection due to a shaft kink.

Event Description

It was reported that during a cryo ablation procedure, the sheath was too tight for the balloon catheter to be advanced into the body.The sheath was replaced and the case was completed with cryo.No patient complications have been reported as a result of this event.The sheath was returned to the manufacturer, analyzed, and subsequently tested out of specification.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7110944
• MDR Text Key: 94832955
• Report Number: 3002648230-2017-00677
• 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: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 24627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• 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: 61 YR