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

Catalog Number	TH-LX-M
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: two turbohawk devices were returned one of the turbohawk units was connected to a cutter driver.No other ancillary units were included.The turbohawk connected to the cutter driver was inspected.The cutter blank was visible in the cutter window.The edge of the cutter was approximately 0.3cm distal the cutter window.Traces of dried blood/biological debris was observed at the cutter mouth and within the cutter window.The thumb-switch was retracted and the cutter pulled back into the cutter.No damages were noted.The thumb-switch was advanced with the cutter driver activated.The cutter advanced approximately 0.8cm distal the cutter window.It should be noted the cutter stopped at the location of the plunger.A 0.014 guidewire from the lab was inserted the cutter mouth of the distal assembly and pushed the plunger towards the cutter window after the cutter was retracted back into the cutter window.Resistance was first encountered while attempting to push the plunger.The plunger then was able to be pushed back into the cutter window.The thumb-switch was advanced a second time.The cutter was able to advance approximately 2.9cm distal the cutter window.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a turbohawk device for treatment of a slightly calcified soft tissue lesion with little tortuosity in the patients mid superficial femoral artery (sfa).Ifu was followed and the device was prepped and inspected prior to use without issue.It is reported the device became jammed and would not close.The physician could turn the cutter off but not completely forward.The cutter was barely closed when the device was removed from the patient.The same issue is reported for a second turbohawk device used in the procedure.A third device h1-lx was used to complete the procedure.No patient injury reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7497768
• Report Number: 2183870-2018-00268
• Device Sequence Number: 16631544
• Product Code: MCW
• UDI-Device Identifier: 00821684065754
• UDI-Public: 00821684065754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• 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
• Report Date (Section B): 05/09/2018

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: 02/06/2020
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A410449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1