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

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

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: management of complications during below-the-knee endovascular treatment: a technical note journal: korean journal of radiology year: 2020 ref: doi: 10.3348/kjr.2019.0743.If information is provided in the future, a supplemental report will be issued.

Event Description

This literature article report is a retrospective study that reviewed the cases in which complications occurred during below-the-knee (btk) endovascular treatments that were performed at konkuk university medical center from 2005 to 2014.Several interesting 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 orno 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 blood flow in at least one btk artery to ensure perfusion to the patient¿s foot.Case 1: btk endovascularangioplasty was performed using an amphiprion deep balloon of 12 cm length and 2.5 mm diameter in the occlusive long segment of the distal posterior tibial artery (pta).Subsequently, a short-segment flow defect was observed in the distal pta and vascular spasm was suspected, including in a segment that appeared normal on angiograms acquired before the balloon angioplasty.After intra-arterial injection of nitroglycerin (200 ¿g/ml; 3 ml) and prostaglandin (5 ¿g/ml; 1 ml) through a microcatheter, the spasm improved.Separate nitroglycerin (3 ml) and prostaglandin (1ml) injections were administered at the same time.

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.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10452989
• MDR Text Key: 204556188
• Report Number: 2183870-2020-00264
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K092299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR