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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Title: short-term efficacy and safety of turbohawk atherectomy for in-stent restenosis in peripheral artery disease: a single-centre experience author: yi qin, yan shi, huawei zhuo journal: anz journal of surgery year: 2022 vol/issue: 1-5 ref: 10.1111/ans.16551.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study which was performed to investigate the curative efficacy and safety of the turbohawk system for in-stent restenosis in peripheral artery disease (pad) patients over 60 years old.28 patients were included in the study.Surgical procedures were performed using the uncovered turbohawk atherectomy device through a femoral artery puncture (modified seldinger technique) under local anesthesia.The uncovered spider fx embolic protection device was placed below the target lesion to prevent distal embolization.Surgery was terminated when the residual stenosis was 30%.One patient who had a hepatoma and long-term history of anti-tumour therapy developed a thrombus (tibiofibular artery) on the first postoperative day and received thrombolytic and anticoagulant therapy.The patient developed foot ulcers and necrosis on the 55th postoperative day and developed restenosis (minimum diameter reduction = 58.96%) on the 76th postoperative day.On the 76th postoperative day, amputation was performed on the right thigh.

• Brand Name: BTK TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13898650
• MDR Text Key: 293177336
• Report Number: 2183870-2022-00101
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• 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 Age: 63 YR
• Patient Sex: Male