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

Model Number	THS-SX-C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: the customer provided three photos of the distal assembly of the turbohawk outside of the patient post-activation.The first photo shows the housing of the distal assembly bent at an approximate 45-degree angle at the proximal are of the stainless steel housing.The bend appears as though it is within the range of the packing stroke of the turbohawk.At the apex of the bend the tecothane is bulging outward with a red/pink tint observed.The damaged tecothane is located on the plane of the housing that is opposite the gw tubing.The photo was unable to determine if the guidewire tubing was damaged.The housing of the distal assembly appeared as if it was filled with biologics.The second photo shows the same damage, but at an opposite angel and the manifold of a pta device most likely.No new observations were noted regarding the condition of the turbohawk.The third photo shows the tecothane was burst.Biological material which was previously excised from the vessel was protruding out from the hole.It cannot be determined if the protr uding material from the housing is only biological.It is unknown if pet from the housing lumen may be included.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a turbohawk atherectomy device during treatment of a plaque lesion in the patient¿s mid and proximal popliteal artery and tibial/popliteal trunk.Slight vessel tortuosity and calcification was reported.Ifu was followed.Vessel pre-dilation was not performed.There was no resistance felt during advancement of the device.No embolic protection was used.It is reported moderate resistance was encountered during withdrawal.It was described that there was a nodule coming out the side of nosecone which caused it to bend the tip.It was described as looking like a large and hard bubble of plaque.The tecothane jacket was not observed to be torn.There was resistance felt when removing the device.The cutter was inside the housing during device removal.There was no vessel damage noted.The device was replaced and the procedure was completed.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10452690
• Report Number: 9612164-2020-03143
• Device Sequence Number: 11676378
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103618
• 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): 08/26/2020

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: 02/26/2023
• Device Model Number: THS-SX-C
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0010139619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1