MAUDE Adverse Event Report: COVIDIEN TRAILBLAZER SUPPORT CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problem Thromboembolism (2654)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This literature article report is a retrospective study which reviewed the cases in which complications occurred during below-the-knee (btk) endovascular treatments that were performed at our hospital from 2005 to 2014.Ten cases have been described herein.All the patients had diabetes and non-healing wounds on their feet and/or rest pain in their foot or leg, and therefore, endovascular treatment was performed for the btk arteries of the affected lower extremity.The complications that occurred during the procedure were classified into six categories¿vascular spasm, flow limiting dissection, perforation, broken guidewire, distal thromboembolism, and unusual puncture site bleeding.Each complication has its own solutions and management.Endovascular procedures were performed under local anesthesia by interventional radiologists in an interventional radiology suite.The common femoral artery (cfa) was punctured using a non-medtronic micropuncture set under ultrasound guidance and sheath insertion was performed.Angiography using non-ionic contrast medium or carbon dioxide (for patients with poor renal function) and digital subtraction angiography were performed through the sheath to evaluate entire lower extremity arteries.In addition to those with only btk artery lesions, some patients had lesions in the ilio-femoropopliteal arteries.Although all affected arteries were treated in these patients, this report only investigated the treatment of btk arteries.The steno-occlusive lesions of the btk arteries were crossed using dedicated 0.018 or 0.014 inch non-medtronic guidewires.A trailblazer support catheter and a non-medtronic guiding sheath were used to provide better support.An antegrade approach was initially attempted by puncturing the cfa.In cases with restricted or no access through the cfa, we attempted retrograde access via the distal btk vessels.In some cases, a pedal or plantar artery approach was also attempted.The btk lesion was passed using these approaches and balloon angioplasty was then performed.During the procedure, complications were detected with a follow-up angiogram and appropriately managed.At the end of the procedure, we confirmed the establishment of bloodflow in at least one btk artery to ensure perfusion to the patient¿s foot.Case 9: it was reported that a focal embolism was detected in the distal anterior tibial artery (ata) during an angioplasty for total occlusion of the ata with a 2.5 mm x 12 cm balloon.The embolism was resolved after aspiration thrombectomy using a 5-fr non-medtronic guiding catheter.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10459218
• MDR Text Key: 204555187
• Report Number: 2183870-2020-00270
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K092299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 08/17/2020
• 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: 79 YR