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

Catalog Number	THS-LX-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a turbohawk with a spider fx and a non-medtronic sheath (7 x 45/terumo) to treat a severely calcified lesion presenting cto (chronic total occlusion 100%) in the mid-right calcified common iliac artery and superficial femoral artery.The vessel presented minimal tortuosity.Artery length and diameter were 6 mm and 30 mm, respectively.Ifu was followed.Moderate resistance was felt upon withdrawal.It was reported that the nosecone detached at the hinge pin when pulling the device back through the sheath.Guidewire prolapse and a torn or ripped lumen was also reported.In order to remove the nosecone, the spider was pulled back into the sheath, where the nosecone was trapped.The procedure was completed using a new 6 mm spider and turbohawk.No patient injury reported.
Additional Manufacturer Narrative
Additional information: it is unknown if the hinge pins were captured with the spider.They were not noted in the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: visual inspection: the turbohawk and spider fx were inspected.It was discovered the housing assembly was fractured and detached from the proximal portion of the distal assembly.The length of the detached turbohawk segment was approximately 9cm.The spider fx capture wire was loaded inside the distal rotating tip of the turbohawk.The housing segment was inspected under microscope.The guidewire tubing of the housing assembly showed a zipper throughout the tubing segment.The proximal end of the detached segment shows a flat end of the tecothane outside layer and the coils within the tecothane stretched proximal.The proximal portion of the turbohawk showed the cutter extended approximately 1.5 cm from the cutter window.The fracture face occurred at the proximal area of where the coils initiate on the housing.It was discovered the housing showed one coil segment stretched out distally with a ductile fracture face.The spider fx filter assembly showed no damages.The location of the distal end of the turbohawk which remained loaded showed the tip of the turbohawk located at the proximal end of the filter.Kinks/bends to the capture wire were noted at approximately 52, 53, and 64cm from the distal tip of the spider fx.A curve to the capture wire was noted at approximately 99cm from the distal tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8149970
• Report Number: 9612164-2018-03548
• Device Sequence Number: 11096084
• Product Code: MCW
• UDI-Device Identifier: 00643169968400
• UDI-Public: 00643169968400
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup,Followup
• Report Date (Section B): 02/26/2019

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: 09/04/2021
• Device Catalogue Number: THS-LX-C
• Device Lot Number: 0009311819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 02/20/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/14/2018; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1