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

Model Number	THS-SX-C
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review the customer provided three cine images.Each image has been evaluated.The first image reviewed shows the distal assembly within the vessel over a guidewire.The customer provided two additional cine images, however, neither image could identified a turbohawk component within the vessel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the turbohawk was returned with a detached cutter driver inside a previously opened pouch which indicated lot 0009537001.No other ancillary devices were included.An inspection of the turbohawk and cutter driver found no damages or anomalies that would appear to have contributed to the reported event.The cutter was advanced within the cutter assembly housing.The length of the housing assembly was approximately 6cm long in accordance with the product labeling tip length of 5.9cm.The cutter was advanced within the housing.The rotating tip guidewire lumen not positioned aligned with the housing.A 0.014" guidewire was front-loaded the distal assembly.The guidewire was able to go through both lumen after aligning the tip assembly with the housing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: there was no tip separation at the hinge pin.After the device was prepped, when loading the device into the wire, the device would not stay lined up, with the black line lined up with the black line at the distal tip.The distal white nosecone tip would not line up with the packaging line on the nosecone.When entering the wire, the wire would not go into the correct alignment due to the fact that the distal tip would not lineup, which would cause it to go into the wrong port lumen.The wire kept coming out on the exit port instead of going into the nosecone lumen port.When the new device was prepped, it went over the wire correctly without any problems.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: no detachment occurred.The device did not enter the patient's body.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a turbohawk device with non-medtronic.014¿ guidewire and 6f sheath to treat a 40mm calcified lesion in the patients left mid popliteal artery.Vessel diameter is reported as 5mm.Moderate degree of calcification and moderate degree of tortuosity reported.The ifu was followed.Size 4 spider embolic protection was used.The vessel was post-dilated.Resistance was felt during advancement, tip was damaged and would not allow device to advance over the guide wire.It was reported that the tip separated at the hinge pin.The procedure was completed using another turbohawk and a nanocross balloon.There was no injury to the patient.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9601129
• Report Number: 9612164-2020-00288
• Device Sequence Number: 584856
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 01/13/2022
• Device Model Number: THS-SX-C
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009537001
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/17/2020; 03/05/2020; 03/10/2020; 03/13/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 01/20/2020; 03/09/2020; 03/11/2020; 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 127