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

Catalog Number	THS-LX-C
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the turbohawk was received for evaluation.No ancillary devices or cine images from the procedure were received.The turbohawk ths-lx-c was received separated from its cutter driver unit and along with its flushing tool.The distal cutter assembly was received separated at the cutter assembly hinge pin.The hinge pins were accounted for.Biological debris was noted distal to the cutter window.Ribbons of polymer debris were noted proximal to the cutter window in the cutter assembly.The source of the polymer debris is unknown but is thought to have come from the ancillary devices such as the support sheath.A 6f support sheath was used while the carton label indicates that the minimal sheath size is 7f.Also the device was used to shave a lesion within a stent.The instruction for use indicates that use of the device for in-stent restenosis in peripheral vascular sites is contraindicated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a turbohawk with a non-medtronic 6f sheath and spider fx to treat a moderately calcified lesion shaving in stent in the superficial femoral artery(sfa).Ifu was followed and the device was prepped without issue.There were no issues noted with device prior to use.It was reported that the device broke in half upon removing it from the sheath.No component embolised in the patient.The procedure was finished when the device was removed from the patient.No deformation of the cutter was noted.No damage to the stent was reported.No patient injury was reported.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8050065
• Report Number: 2183870-2018-00503
• Device Sequence Number: 11169118
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/08/2018

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: 04/18/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A447270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1