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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0010499679 was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked at 2.2 inches from the tip.The shaft tip was intact with no apparent issues.The kink could cause deflection or steerability or insertion difficulties.In conclusion, 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
After a completed case, the sheath subsequently tested out of specification per the manufacturer's investigation.

• 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: 11871881
• Report Number: 3002648230-2021-00261
• Device Sequence Number: 14269968
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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 Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010499679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1