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

Model Number 4FC12

Device Problems Air Leak (1008); Material Integrity Problem (2978)

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, after the was inserted into the patient's body and the air in the balloon catheter was removed, the balloon catheter was inserted into the valve of the sheath, and air was attempted to be introduced through the side port of the sheath, however, air was continuously introduced during aspiration.Although the issue was resolved once, the air was continuously introduced through the side port again when the balloon catheter was advanced to the sheath by approximately.Therefore, it was considered as a hemostatic valve issue and the sheath was replaced.After the left superior pulmonary vein (lspv) ablation was completed, during left inferior pulmonary vein (lipv) ablation, a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable.The procedure was continued by touching the "continue" button.During right inferior pulmonary vein (ripv) ablation, a system notice was received indicating a mechanical component error.After checking if the scavenging hose was bent, it was observed that the plug of scavenging facility was unlocked.In addition, as frost on the connector of the coaxial umbilical cable and balloon catheter was noted, the coaxial umbilical cable was replaced.Thereafter, during the second ripv ablation and the initial right superior pulmonary vein (rspv) ablation, the frost on the connector of the second coaxial umbilical cable and 2af284 balloon catheter was also noted.However, as no system notice was received, the procedure was continued and completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files showed that 10 applications were performed with a balloon catheter on the date of the event.System notices had occurred indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable (#50001) and there was a mechanical component error.Also, the flow was fluctuating in multiple applications.Visual inspection of the sheath showed a shaft kink 2.57 inches from the tip.The kink may have occurred post-procedure.Aspiration/flushing test did not show any air passing through the tube or expelled from the sheath distal tip.Multiple aspirations / injections were performed without air bubbles or leaks through the hemostasis valve when a test balloon catheter was introduced through the sheath.Hemostasis valve was leak tight.In conclusion, the sheath passed the performance test as per specification.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: 7663817
• MDR Text Key: 113289411
• Report Number: 2184009-2018-00016
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 14072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR