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

Catalog Number	THS-LX-C
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the returned turbohawk device revealed no damage to the slide cover assembly or the torque shaft.The distal assembly was inspected and found no tissue/biological matter within laser drilled coils segment.The cutter blank was visible in the cutter window.The distal rim of the cutter window on the top portion was cut away.The portion of the cutter window cut away was not located.Approximately 0.25 cm distal the cutter window the laser drilled coils were bent inwards.The thumb-switch was retracted and was able to pull the cutter back into the cutter window as expected.The thumb-switch was attempted to be advanced, however it could not pass the location where the cutter was originally located as it was received.The cutter could not advance due to the indentation of the laser drilled coils distal the cutter window.
Event or Problem Description
Physician intended to use a turbohawk directional atheterctomy device with a 8fr sheath and 0.014¿ guidewire for the treatment of a lesion in proximal location of the superficial femoral artery/ popliteal artery/ tibial/popliteal trunk of moderate tortuosity.The device was inspected prior to use with no issue noted.No abnormalities reported in relation to anatomy.Ifu (instruction for use) followed during preparation, procedure, post-procedure.The vessel was pre-dilated.It was reported that difficulty was encountered with flushing tissue during the procedure.It was reported that after flushing the device more than 10 times, the blade still could not move.The physician post-dilated the lesion by pta balloon to complete the procedure.Operation was extended for 1.5 hours due to the replacement of device.No patient injury reported.Patient¿s status was reported to be well.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7016509
• Report Number: 2183870-2017-00488
• Device Sequence Number: 16315010
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 08/23/2019
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A332627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80