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

Catalog Number THP-M

Device Problem Material Deformation (2976)

Patient Problem Embolism/Embolus (4438)

Event Date 01/26/2024

Event Type  Injury  

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.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.

Event Description

A physician was attempting to use a turbohawk plus atherectomy device during treatment of 400mm plaque lesion in the patient¿s left proximal mid distal superficial femoral artery (sfa), popliteal artery (pop), tibial/popliteal trunk (tpt), and posterior tibial artery (pta).Moderate vessel tortuosity and moderate vessel calcification were reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter reported as 6-3mm.There were no abnormalities reported in relation to anatomy.The device was inspected with no issues noted.The device was prepped per the ifu with no issues identified.Physician crossed subintimal in sfa and pop re-entered into true lumen into tpt, predilitated the whole cto segment with a 3x150 nanocross.A 4mm spider was placed into distal pt.Several passes were made and a bend of blade was noticed angiographically.Once physician tried to remove the device, resistance was felt coming into the sheath.Device was torqued several times and gently removed.Once outside of the patient the bulge on the nosecone was physically visible.Device was cleaned per ifu and soft plaque was extracted.A new device was open to complete the hawking.After the second device was used to hawk out the plaque, a 3x150 pta was used in tpt and pt and a 5x150 ipa was used in pop and sfa.After angiogram, emboli was identified in the spider filter.Once the filter was removed, another emboli was identified inthe distal pt.An 035 trailblazer was advanced into distal pt and after several attempts to aspirate, the emboli was removed with vessel patent.It is not clear at what stage the embolism occurred what device may have have contributed to it.

Manufacturer Narrative

Product analysis the device was returned with a bulge on the housing approximately 18mm from the cutter window and the cutter is stuck in the bulge.Housing wall and tecothane are intact medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18766646
• MDR Text Key: 336102717
• Report Number: 9612164-2024-00919
• Device Sequence Number: 1
• Product Code: MCW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: THP-M
• Device Lot Number: 0011051373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: Female