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

Catalog Number	TH-LX-M
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use a turbohawk directional atherectomy device to treat a lesion in an unknown location.A non-medtronic guidewire was used.The device was removed from its packaging and inspected with no issues noted.The ifu was followed during the procedure.The physician reported that they were able to open the cutter and operate the device within the lesion, but the device would not completely close.There was no issue packing the nosecone.It is unknown if the cutter was returned fully to the housing before the device was removed from the patient.The physician commented that it was possible that a piece of plastic from the guide catheter might be lodged in the device.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the turbohawk was returned for evaluation.The device was attached to a cutter driver.No other ancillary devices were included.The turbohawk was inspected and the hinge for the distal assembly was observed to be loose.The thumb switch was retracted back, however, the cutter assembly remained approximately 1cm distal to the cutter window.The cutter window was empty, no sign of the drive shaft or cutter assembly.It was discovered the drive shaft fractured from the cutter assembly.The distal assembly was cut open in order to retrieve the cutter assembly.The bond between the drive shaft and the cutter window was observed to be intact.The drive shaft fractured at the location of the proximal end of the cutter assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7123510
• Report Number: 2183870-2017-00585
• Device Sequence Number: 1288004
• Product Code: MCW
• UDI-Device Identifier: 00821684065754
• UDI-Public: 00821684065754
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/15/2018

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: 08/02/2019
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A320798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1