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

Model Number	THS-LX-C
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: three photographic images were returned for review.The first photographic image contained the turbohawk catheter, including the han dle and thumb-switch and the distal assembly.The device was wrapped loosely in a circle.No anomalies were noted with the handle of the device.The thumb-switch appeared to be in advanced.No fractures or bends were noted within the handle.Inspection of the catheter revealed no anomalies.The quality and clarity of the image was not sufficient to identify any anomalies with the device¿s distal assembly.The second photograph contained the device distal assembly.The cutter appeared to be located within the housing assembly.Due to the angle of the device in the photograph, the drive shaft and cutter window were not clearly visible.No bends or kinks in the housing assembly were visible within the photograph.Additionally, no biological debris was observed in the distal housing assembly.The third photograph contained the device label on the sterile label pouch and the distal assembly.The label indicated that the device lot number was a514375, consistent with the reported device.The cutter appeared to be within the housing assembly of the device.No damage was noted to the housing.Due to the quality and clarity of the image, the drive shaft and cutter window were unable to be examined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use turbohawk directional atherectomy during procedure to treat a severely calcified plaque in the mid superficial femoral artery (sfa) with 80% stenosis.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that when the switch was operated, the cutter was stuck and could not be retracted, and resistance was felt.It was possible to advance the cutter within the housing and they were unable to retract the cutter into the cutter window.The cutter was located outside the cutter window.It was not possible to turn the thumbswitch off.The cutter driver/thumbswitch did not stop functioning while in use in patient.The device was safely removed from the patient.There was no deformation noted in the cutter.No pieces of the cutter were missing.A non-medtronic product was used to complete the procedure.There was no patient injury 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: 10223250
• Report Number: 2029214-2020-00647
• Device Sequence Number: 595240
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 08/24/2020
• Device Model Number: THS-LX-C
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A514375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR