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

Catalog Number	THS-SX-C
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
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 intended to use a turbohawk device with a non-medtronic 7fr sheath and 0.014 spider fx embolic protection device during treatment of a 200mm plaque cto (chronic total occlusion-100%) in the patient¿s distal superficial femoral artery (sfa) of diameter 4mm.No tortuosity or calcification were reported.Ifu was followed and the device was prepped without issue.The vessel was pre-dilated.It was reported that the thumbwheel became jammed when trying to turn off the cutter and pack the plaque in the nosecone.It would not go all the way forward and stayed on.A new turbohawk device was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received: the device was removed from the patient with the cutter in the housing.The device was safely removed from the patient.No issue observed with the cutter, all components were removed from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the distal flush tool was removed and inspected the device.The cutter and thumb switch were in the retracted position.Biological debris was observed on the external area of the housing.No damages to the turbohawk were observed that would appear to have contributed to cutter advancement difficulty.The cutter driver was activated, and the thumb switch was advanced.The cutter advanced approximately 2.8cm distal 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): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8310004
• Report Number: 2183870-2019-00060
• Device Sequence Number: 14002824
• Product Code: MCW
• UDI-Device Identifier: 00821684065853
• UDI-Public: 00821684065853
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/20/2019

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: 09/20/2019
• Device Catalogue Number: THS-SX-C
• Device Lot Number: A346719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/13/2019; 05/07/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/07/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR