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

Model Number THS-SS-CL

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9361606
• MDR Text Key: 167664701
• Report Number: 9612164-2019-04857
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR