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

Model Number	THS-SS-CL
Medical Device Problem Codes	Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a turbohawk btk device with a 6fr sheath during treatment of a plaque lesion in the patient¿s mid left anterior tibial artery.Moderate vessel tortuosity and calcification are reported.Lesion exhibited 90% stenosis.The lesion length was 40 mm.Ifu was followed.Pre-dilation was not performed.No embolic protection was used.Resistance was felt during advancement of the device.It is reported the device was sticking while trying to torque and then would spin in the artery without any passes made with the device.No treatment was given with this device.The device was safely removed from the patient with the cutter blade inside the housing.The artery was stented to complete the procedure, which was not part of the planned original procedure.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the device was returned to medtronic investigation lab for evaluation.There were no ancillary devices or images returned.There was a slight bend in the torque shaft beneath the strain relief.Biological debris was noted within the distal housing.It was noted that the cutter driver was returned in the "on" position.The cutter was returned just distal to the cutter window.No damage was noted to the guide wire lumen upon inspection.A 0.014" guide wire was back loaded onto the turbohawk device.No anomalies or resistance was noted during insertion of the guide wire.The od of the device was taken.The device and guide wire were then inserted into a 6 fr sheath.No anomalies were noted during insertion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9339761
• Report Number: 9612164-2019-04787
• Device Sequence Number: 11314707
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: THS-SS-CL
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009791497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 98