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	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0010460482 was returned and analyzed.Visual inspection of the sheath showed the shaft is kinked at two locations (at the strain relief distal and at 2 inches from the tip).Deflection functionality of the sheath was within specification.The tip of the sheath was atraumatic and the inner diameter measurement of 0.157 inches was within specification (should be 0.158 +0.002/-0.001 inches).A balloon test catheter, under vacuum and with push button in the forward position, was threaded into the sheath and resistance was observed when the catheter reached the first kink at the strain relief.The kink distal (2 inches from the tip) prevented smooth steerability.X-ray imaging showed deformed breaded wires restricting the insertion.Both the sheath distal tip and dilator tip were intact, no fracture, breakage, or kink were noticed.The outside diameter measurement of the dilator was 0.153 inches and was within specification (should be 0.154 +/- 0.001 inches).The dilator was threaded into the sheath and resistance was observed when the dilator reached the first kink at the strain relief.Dissection and pressure of the sideport did not show any obstruction or leak.In conclusion, the sheath failed the performance test due to shaft kink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The sheath subsequently tested out of specification per the manufacturers 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: 11437121
• Report Number: 3002648230-2021-00098
• Device Sequence Number: 3853137
• 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): 03/08/2021

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 Expiration Date: 11/26/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010460482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR