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

Catalog Number	THS-LX-C
Medical Device Problem Codes	Break (1069); Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary the turbohawk was returned and a cutter driver was also included the box which showed a product label indicated lot a300456.Prior to removing the turbohawk from the tray it was discovered the distal assembly was separated from the torque shaft adapter.The turbohawk was removed and noted the thumb-switch was in the forward position and the cutter was retracted back into the cutter window.The torque shaft of the unit and the distal assembly were held together as one unit by the cutter assembly and drive shaft.Approximately 3 cm of the drive shaft was exposed between the torque shaft and the distal assembly.The hinge pins were accounted for and remained present.One of the two hinge pins was bent proximally at an approximate 90 degree angle.The torque shaft adapter was inspected and found no anomalies that would appear to have contributed to the separation.No damages or anomalies were noted to the cutter driver.The thumb-switch was retracted and the distal assembly followed and showed the torque shaft adapter align with the distal assembly.All components accounted for.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using a turbohawk atk device for treatment of a lesion in the superficial femoral artery (sfa).No lesion information provided.Sheath size and brand unknown and unknown if embolic protection was used.Issue was guidewire prolapse.It is unknown if the device was pushed over the bifurcation.The guidewire was flushed.Unknown resistance was felt when delivering the device.It is unknown if the tip was damaged or caused embolism.The procedure was completed by implantation of one stent.Unknown if there were any patient symptoms or complications associated with this event.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6906566
• Report Number: 2183870-2017-00425
• Device Sequence Number: 566308
• 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): 09/21/2017

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: 09/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1