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

Model Number THS-SX-C

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  Injury  

Event Description

Physician was attempting to use a turbohawk directional atherectomy along with 6fr sheath and nitrex guidewire during procedure to treat a moderately calcified plaque lesion with soft tissue in the left proximal to mid tibial/popliteal trunk (tpt), posterior tibial artery (pta) and anterior tibial artery (ata) with 75% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 3mm and 5mm - 10mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.During advancement, moderate resistance was felt and the tip detached but did not separate at the hinge pin.It was reported that access was pedal approach using a 6fr slender sheath.After treating ata using atherectomy in a retrograde fashion, attempting to treat pta which was done with two passes, at the third attempt, felt resistance, noticed the tip of the device detached, remaining in pta as the device was removed from the body.Physician gained pta access, used an endovascular grasper alligator being able to remove the entire tip, leaving no foreign body in the artery.Afterwards, sheaths were removed and closed using a 4-0 monocryl suture.Procedure was completed in a safe fashion, no injuries or foreign body event.There was no further injury to patient.Patient went home after two hours.

Manufacturer Narrative

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

Manufacturer Narrative

Image review: the customer returned one image.The image appears to show the distal end of a turbohawk device and with its detached tip.The detached tip appears to be held by a snare device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12820105
• MDR Text Key: 280818329
• Report Number: 9612164-2021-04436
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: THS-SX-C
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0010747378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Date Device Manufactured: 07/02/2021
• 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
• Patient Sex: Male