MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96820-112

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

Patient Problem Embolism/Embolus (4438)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

Article details: title: cerebral protection using percutaneous normothermic bilateral antegrade cerebral perfusion during total arch tevar in a patient with shaggy aorta authors: george joseph, rahul pillai, vinayak shukla, krothapalli s.Babu, shankar manickam, viji samuel thomson, korah t.Kuruvilla, roy thankachen, elizabeth joseph, and raj sahajanandan journal name: journal of endovascular therapy, vol.27(3) 405¿ 413, 2020 doi: 10.1177/1526602820915940.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding cerebral embolic protection (cep) designed for use during thoracic endovascular aortic repair (tevar).The technique is demonstrated in a (b)(6)-year-old male smoker with hypertension and dyslipidemia who was incidentally found to have mediastinal widening on chest radiography.The cep system provided bilateral normothermic acp through percutaneously inserted 12-f and 10-f bio-medicus pediatric arterial cannulas in the right axillary artery (raa) and lcca, respectively.The procedure was performed under general anesthesia after obtaining written informed consent from the patient for the planned procedure and for use of a physician-modified endograft.The mean arterial pressure was maintained above 90 mm hg throughout the procedure.No spinal drain was used.The patient was kept heparinized throughout the procedure, with the activated clotting time maintained at 350 to 400 seconds.The procedure was entirely percutaneous.Duplex ultrasound guidance was used to obtain bilateral femoral arterial and venous, bilateral brachial, and antegrade and retrograde lcca accesses.Dual retrograde raa accesses were obtained using a pigtail catheter inserted from the right brachial artery as a marker.The antegrade lcca access and 1 of the 2 raa accesses were used to insert the short (10-cm) 10-f and 12-f bio-medicus cannulas, respectively, over 0.035-inch guidewires using appropriate dilators.  during the procedure there was slow oozing of blood around the lcca cannula leading to formation of a left neck hematoma.The oozing stopped immediately after removal of the cannula.As a precautionary measure, the patient was extubated the next morning after confirming that there was no increase in size of the neck hematoma.The in-hospital course was otherwise uneventful.There were no neurological deficits or other complications.Postoperative magnetic resonance imaging of the brain showed few small embolic infarcts confined to the right frontal and left cerebellar regions.It was noted that the small embolization that did occur in the present case was probably because the raa cannula flow rate was not sufficiently high; however, this did not result in any early or late neurological deficit.The authors feel that this is acceptable given the extremely diseased nature of the aorta in this patient, a situation where massive cerebral embolization is possible during arch tevar without cep.

• Brand Name: BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11775537
• MDR Text Key: 248986278
• Report Number: 2184009-2021-00029
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143083
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96820-112
• Device Catalogue Number: 96820-112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 05/05/2021
• 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): Hospitalization
• Patient Age: 76 YR