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

Model Number 4FC12

Device Problems Defective Device (2588); Difficult to Advance (2920); Gas/Air Leak (2946)

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

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the stopcock was intact with no apparent issues.Also, the shaft was kinked 1.6 inch from the tip of the shaft.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking and a torn valve disk was suspected.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 sheath could not be smoothly operated.Additionally, upon inserting the balloon catheter in the sheath several times, air was continuously introduced, and when the sheath handle was operated, the curve shape was insufficient.It was also reported that the torque was difficult to be applied on the sheath.Therefore, the sheath was replaced which resolved the issues.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed 26 injections were performed with a balloon catheter on the date of the event without any issue.A system notice 50013 ¿the refrigerant level is too low to continue¿ unrelated to the reported malfunction was triggered.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7728539
• MDR Text Key: 115670528
• Report Number: 3002648230-2018-00504
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 04535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/05/2018; 08/08/2018
• Supplement Dates FDA Received: 08/31/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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