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

Model Number	4FC12
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot number 85392 was returned and analyzed.Visual inspection of the sheath showed the shaft was intact with no apparent issues; the reported air ingress issue could not be reproduced.Multiple aspirations / injections were performed without air bubbles or leaks; the hemostatic valve was leak tight.A pressure test did not show any leak on the shaft, side tube and hemostasis valve.In conclusion, the reported sheath air ingress issue was not confirmed through testing.The sheath passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryoablation procedure, air ingress was observed when the balloon catheter was inserted into the sheath.It was noted the valve may not have been functioning properly.The sheath was replaced, and the same issue occurred.The sheath was replaced a third time with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 8907945
• Report Number: 3002648230-2019-00603
• Device Sequence Number: 2730901
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 85392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4FC12 SHEATH