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

Catalog Number	THS-LX-C
Medical Device Problem Codes	Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
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
The physician intended to use a turbohawk device for the treatment of a moderately calcified lesion in the mid right superficial femoral artery (sfa).The vessel was reported to be slightly tortuous.It was reported that the cutter would not close and was jammed when trying to advance the thumbswitch.The technician explained that the cutter thumb switch would not advance forward when trying to close the cutter inside patient.The blade jammed and would not close while in use in the patient.The device was safely removed from the patient.No deformation noted in the cutter.The procedure was completed with another device.No patient injury reported.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9755 toledo way; irvine CA 92618
• MDR Report Key: 7366069
• Report Number: 2183870-2018-00183
• Device Sequence Number: 19372281
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111723
• 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): 03/23/2018

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: 05/14/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A460027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 77