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

Catalog Number THS-SX-C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a turbohawk device with a non-medtronic 6fr sheath and a 0.014 300cm nitrex wire to treat a 150mm plaque, 90% stenotic lesion in the patient¿s mid superficial femoral artery (sfa).The vessel diameter was reported as 6mm with severe tortuosity.The ifu was followed during preparation, procedure and post procedure.The vessel was not pre-dilated.It was reported that the atherectomy was performed.The physician encountered high resistance while attempting to remove the device.After 2/3 attempts, the device was removed.After inspection, it was noticed that the nosecone was detached.Attempts to retrieve it with a snare were unsuccessful so the physician decided to cage the nosecone with a self-expanding stent.The vessel was post dilated.The physician was satisfied with the angiographic results.No patient injury was reported.

Manufacturer Narrative

Additional information: the nose cone detached in the mid sfa.The snare used was a non-medtronic device.A medtronic everflex stent was used to cage the detached nose cone to the vessel wall.There were no patient complications reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the hawkone device was returned for analysis.No ancillary device or images were received with the device.The cutter driver was not returned with the hawkone.Inspection of the hawkone revealed the distal assembly contained biological debris throughout.The distal rotating tip was detached from the assembly just distal to the flush window; the rotating tip was not returned.The tecothane remained intact.Multiple bends were noted throughout the housing, the housing was bent in a ¿c¿ shape.The inner coils at the proximal end of the device were bent and separated.The inner coils at the distal end were stretched and pulled and were protruding out from the distal end.The cutter remained attached and was approximately 2.0cm distal to the cutter window.Microscopic inspection of the guidewire lumen revealed a zipper tear throughout the assembly.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: 8788596
• MDR Text Key: 150956573
• Report Number: 9612164-2019-02846
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009657185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• 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 Outcome(s): Required Intervention