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

Catalog Number	THS-SS-CL
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	10/11/2019
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
Physician used a turbohawk device during treatment of a plaque lesion in the patient¿s distal popliteal artery.Slight tortuosity and no vessel calcification are reported.Ifu was followed.No resistance was felt.It is reported that tip detachment occurred.The tip is not reported to have separated at the hinge pin.The tip where nosecone can be aligned detached right at the end of sheath, so they were able to remove safely.A new hawkone was then used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the tip was partially detached.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 9190117
• Report Number: 9612164-2019-04358
• Device Sequence Number: 16794175
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/16/2020

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: 05/26/2022
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009758183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 01/15/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/17/2019; 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1