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

Catalog Number	TH-LX-M
Medical Device Problem Codes	Device Operational Issue (2914); Material Deformation (2976)
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driver.No other ancillary units were included.The turbohawk not connected to the cutter driver was inspected.The cutter was retracted back into the cutter window.The proximal end of the guidewire tubing was flared out and partially separated from the distal assembly; however the tubing did not separate from the distal assembly.Dried blood/biological debris was observed within the inner diameter of the coil segment.The thumb-switch was retracted and the cutter pulled back into the cutter window further exposing the cutter rim.It was observed debris was discovered on the cutter head.It was removed using a tweezers and submerged in water.The consistency of the material was soft, consistent with that of biological material.The returned cutter driver was attached to the turbohawk.With the cutter driver activated the thumb-switch was attempted to be advanced.The cutter could not advance past the original location the unit was returned.Under microscope a bend to the coil segment at the area distal the vent holes showed a crease/evidence of bending.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 in the patients mid superficial femoral artery (sfa).Ifu was followed and the device was prepped 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 same is reported for a second device in the procedure.The cutter was barely closed when the device was removed from the patient.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: 7497748
• Report Number: 2183870-2018-00267
• Device Sequence Number: 1768947
• 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: 01/04/2020
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A395361
• 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