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

Model Number 4FC12

Device Problems Air Leak (1008); Kinked (1339)

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

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the bin files and sheath, 4fc12 with lot number 57810 were returned and analyzed.The bin files showed multiple applications were performed on the date of the event and several applications were non-sustained.Visual inspection of the sheath showed the device was kinked.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking, the valve was torn.In conclusion, the sheath failed the return product inspection due to a leaking hemostatic valve and shaft kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, attempts to aspirate fluid through the sheath were unsuccessful.It was indicated that only air would aspirate from the side port.Several attempts were made to draw back fluid without success.The sheath was replaced without resolve.The balloon catheter was then replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.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: 6994015
• MDR Text Key: 91236329
• Report Number: 3002648230-2017-00591
• 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: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 57810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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: 62 YR
• Patient Weight: 80