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

Catalog Number	THS-LS-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation visual inspection found that the cutter driver was located within the distal assembly approximately 1.0cm distal to the cutter window.Microscopic examination of the cutter window revealed no anomalies.Dried blood was observed on the torque shaft and inside the cutter window.The thumbswitch was attempted to be advanced; however, the thumb switch was unable to be advanced.The returned turbohawk was connected to a cutter driver from the lab and the cutter was able to successfully power and retract.The cutter was examined under the microscope and no anomalies were noted.Biological debris was noted on the distal end of the cutter.The cutter was attempted to be advanced again; however, the cutter was unable to be advanced past 1.0cm, biological debris was noted at the location of the of the cutter.The device was then flushed and the cutter was advanced again.The cutter was able to successfully advance 2.6cm distal to the cutter window.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a turbohawk atk with a non-medtronic (abbott) 0.014 guidewire during treatment of a 40mm plaque calcified 70% stenotic lesion in the patient¿s mid superficial femoral artery (sfa) of diameter 5mm.No tortuosity along with moderate calcification were reported.Ifu was followed and the device during prep.It was reported that the device jammed during prep and would not close.The thumbswitch was unable to open and close the cutter.No deformation or damage was noted to the tip.Motor issues were experienced when attempted to be turned on and off.Device not used in patient.No allegation noted with spider fx device mentioned.When the device was returned to the manufacturing facility it was noted to be damaged.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8793664
• Report Number: 2183870-2019-00371
• Device Sequence Number: 13947687
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 07/17/2020
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A493157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 48