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

Model Number	THS-SS-CL
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
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
Physician was used a turbohawk directional atherectomy to treat a severely calcified, little tortuous lesion in the mid sfa with 85% stenosis.The lesion was not pre dilated but post dilated.The ifu was followed during preparation, procedure and post procedure.It was reported that the tip detached during removal of the atherectomy catheter while it was inside the sheath.The atherectomy catheter was removed (all pieces) and an everflex stent was implanted.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the sheath stayed in the body to complete the procedure.All parts of the turbohawk, including the tip, were removed over the wire.The implant of the everflex stent at the end of the procedure was pre-planned.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the turbohawk device was received for analysis.No ancillary device or images were returned with the device.The cutter driver was not returned with the device.Biological debris was noted throughout the distal assembly.A radial fracture was observed between the anchor pockets and proximal end of the coiled segment of the housing.The inner housing coils were protruding out from the proximal end of the housing.Microscopic inspection of the window assembly revealed no anomalies with the window assembly.The cutter remained attached to the drive shaft.The cutter was advanced just past the cutter window but remained within the cutter window assembly.Inspection of the protruding inner laser drilled coils revealed stretching and bending of the coils.The fracture face of the coils appeared to be curved and rough, consistent with excessive force.Microscopic examination of the guide wire lumen revealed the distal end of the guide wire lumen of the distal housing assembly was torn and detached.The remainder of the guide wire lumen remained intact with no anomalies noted.Examination of the rotating distal tip guide wire lumen revealed no anomalies.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: 9361606
• Report Number: 9612164-2019-04857
• Device Sequence Number: 19464133
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• 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,Followup,Followup
• Report Date (Section B): 02/17/2020

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: 05/26/2022
• Device Model Number: THS-SS-CL
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009758183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 02/14/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 11/27/2019; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR