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

Model Number	4FC12
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0010314891 was returned and analyzed.Visual inspection showed the sheath shaft was kinked and twisted around, 1.86 inches from the tip.The kink prevented smooth steerability when a test balloon catheter was inserted.The sheath distal tip was intact with no fractures, breaks or kinks noted.No teflon delamination was noted at the tip of the sheath shaft.Functional testing of the sheath showed the deflection worked as per specification.In conclusion, the reported kink was confirmed.The sheath failed the returned product inspection due to a shaft kink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, the sheath appeared to be more curved than normal and it was suspected that a possible kink occurred.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: 10817946
• Report Number: 3002648230-2020-00580
• Device Sequence Number: 16672616
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/10/2020

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: 08/13/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010314891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1