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

Model Number	4FC12
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cryo ablation procedure, while aspirating the sheath after balloon was inserted, only air was being pulled back.This occurred with three sheaths which were all replaced in addition to the balloon catheter.The procedure was continued and completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: device was returned and analyzed.Visual inspection of the sheath showed that the device was intact with no a pparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.A dissection showed that the hemostatic valve was leaking.In conclusion, the reported issue has been confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6296420
• Report Number: 3002648230-2017-00061
• Device Sequence Number: 10881416
• Product Code: DRA
• UDI-Device Identifier: 00643169504707
• UDI-Public: 00643169504707
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2017

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: 08/03/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 58742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/03/2017; 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1