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

Model Number	990065
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the sheath, 990065 with lot number 51301, was returned and analyzed.Visual inspection of the sheath showed that the shaft as kinked (pinched) at 2.328 inches proximal from the tip.Functional testing showed the deflection mechanism was working with difficulty due to the kinks on the shaft; the pull wire was not broken.In conclusion, the sheath failed the returned product inspection due to the 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 radiofrequency (rf) procedure, the sheath was having difficulty maneuvering.It was then observed the sheath was kinked and was replaced.The second sheath also had maneuverability issues and was able to be manipulated with resolve in order to perform rf.The case was completed with radiofrequency.No patient complications have been reported as a result of this event.The second sheath subsequently tested out of specification per the manufacturer's investigation.

• Brand Name: FLEXCATH SELECT STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 8933550
• Report Number: 3002648230-2019-00622
• Device Sequence Number: 2000815
• Product Code: DYB
• UDI-Device Identifier: 00643169688858
• UDI-Public: 00643169688858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 03/24/2021
• Device Model Number: 990065
• Device Catalogue Number: 990065
• Device Lot Number: 51301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1