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

Model Number THP-M

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

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.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.

Event Description

A physician intended to use a turbohawk plus atherectomy device during treatment of a 60mm soft tissue plaque lesion in the patient¿s right mid proximal popliteal artery.Little vessel tortuosity and little vessel calcification are reported.Artery diameter is reported as 4.9mm.Lesion exhibited 70% stenosis.Device was inspected with no issues noted.Ifu was followed and the device was prepped without issue.It is reported cutter driver thumb switch was unable to fully extend to ¿off¿ position.Physician made one successful pass with the device.After his second pass, the tech was unable to fully turn the cutter driver thumb switch to the off position.After a few unsuccessful attempts to fully close and pack the device, the physician removed the atherectomy catheter from the patient for cleaning.The tech cleaned the device per ifu and saw plaque be removed from the nosecone.After 3 flushes with a 3cc syringe, the tech then prepped the device to be able to make more passes.Before loading the catheter, the tech and physician were both unable to turn the thumb switch to the full off position.For a final attempt, the physician disconnected the catheter from the cutter driver and then attempted to re-prep the device with no success.A new turbohawk plus catheter was opened, inspected, and prepped per ifu with a new cutter driver.After one pass with the new device, the same issue of the thumb-switch not fully extending to theoff position was noted.The tech removed the device and cleaned per ifu and the exact same situation occurred.A bit of plaque was seen to be flushed, but after multiple flushes and re-prepping the device for usage, the cutter driver thumb switch was unable to fully turn to the off position.No deformation was noticed in the cutters in the on position (both with the driver battery pack on and off), it was hard to do a thorough inspection after removal as the thumb switch was unable to fully extend to the off position to see clearly.The devices were safely removed from the patient.During inspection, no pieces of the cutters were noted to be missing.The exact position of the cutter was unknown during removal of both devices.The physician then used a 4x60 nanocross for dilation.After pta, the physician used an.035 trailblazer catheter to remove the 3mm spider with no additional issues noted.No patient injury reported.

Manufacturer Narrative

Product analysis the device was returned with the thumbswitch approximately halfway between the ¿on¿ and ¿off¿ position there is no biologics in the housing and the cutter is positioned at the distal end of the cutter window the thumbswitch was retracted and the cutter returned to the cutter window and rotated the thumbswitch was advanced and the cutter advanced approximately 25mm into the housing the thumbswitch and cutter could be retracted and advanced 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: 17070265
• MDR Text Key: 316585185
• Report Number: 9612164-2023-02398
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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: 0011622483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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