MAUDE Adverse Event Report: MEDTRONIC IRELAND BTK TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THS-SX-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using aturbohawk to treat a plaque lesion with 50% stenosis in the distal tibial/popliteal trunk.Ifu was followed.The vessel was not pre-dilated.No resistance was felt.It was reported that the tip of the device detached and the damage was described as ¿black line was coming off¿.The tip did not separate at the hinge pin.Another device was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a non-medtronic 6fr, 45cm sheath was used with a 0.014, 300mm nitrex wire.No resistance was experienced during removal.The device was removed in one piece from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation the turbohawk was removed from the packaging and inspected.The cutter was positioned forward inside the coiled housing.The proximal end of the guidewire tubing was flared upwards.The flaring started at the proximal end of the guidewire tubing and continued approximately 0.3cm.The coiled housing showed a bend approximately 0.4cm from the cutter window.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8481966
• Report Number: 9612164-2019-01164
• Device Sequence Number: 11156979
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103618
• 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): 07/17/2019

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: 01/13/2022
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009537001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 07/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/09/2019; 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1