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 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot 24668, was returned and analyzed.Visual inspection of the sheath showed the device shaft was kinked 0.9270 inches from the tip.In conclusion, the reported issue was confirmed through testing.The sheath failed the returned product analysis due to a shaft kink near the tip.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the steering mechanism on the sheath was broken.The sheath was not replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.(b)(6) 2017 the sheath subsequently, 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7024093
• MDR Text Key: 92737326
• Report Number: 3002648230-2017-00609
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 24668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2017
• 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