MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number THP-M

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a turbohawk plus directional atherectomy during procedure along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a moderately calcified soft tissue lesion in the right mid superficial femoral artery (sfa) and popliteal artery (pop) with 60% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 5mm and 40mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.Tip detachment/damage occurred with a moderate resistance felt during advancement.The tip did not separate at the hinge pin.It was reported that after the first pass/cut was made with the turbohawk, when tech pulled thumb switch back to turn off device, it did not want to completely shut off.Therefore, the tech proceeded to turn off the battery pack and the device was removed.The physician did not want to waste time and asked for the device to be put in a biohazard bag.A hawkone was then attempted to continue procedure, and it was reported that when advancing the hawkone-s, physician felt a lot of resistance, after getting it through the sheath, the device performed well.When removing the device, physician felt event more resistance than when advancing it.The catheter came out without the nosecone.The nosecone stayed stuck in the proximal end of the sheath.Physician continued to remove wire, while thinking of removing the entire sheath, but then the detached tip came out with the wire.Physician used another hawkone-s, and post dilated the sfa and popliteal arteries with an evercross 5x150 pta balloon.There is no patient injury reported.

Manufacturer Narrative

Additional information: the cutter of turbohawk plus was outside housing in relation to the nosecone during device removal from the patient.The device was safely removed from the patient.No deformation was noticed in the cutter, aside from it being detached.No pieces of the cutter were noticed to be missing.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.

Manufacturer Narrative

Product analysis the device was returned with the thumbswitch fully advanced to the ¿off¿ position and the cutter is positioned approximately 28mm inside housing, (photo 5).The thumbswitch was retracted and the cutter returned to the cutter window when the thumbswitch was advanced the cutter advanced approximately 28mm into the housing without issue.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: TURBOHAWK PLUS 6FR
• 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: 14248001
• MDR Text Key: 290461718
• Report Number: 9612164-2022-01631
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00763000402396
• UDI-Public: 00763000402396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212027
• 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,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: THP-M
• Device Catalogue Number: THP-M
• Device Lot Number: 0010957355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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 Sex: Female