MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY

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

Patient Problems Hemolysis (1886); Renal Failure (2041); Hematuria (2558)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Bsc aware date: used event notification date as bsc aware date since none was provided.Date of event was approximated based on publish date of article.Initial reporter address 1: (b)(6).Xiaofeng han, guangrui liu, tiezheng li, and xi guo, beijing, china.Application of the angiojet ultra thrombectomy device for the percutaneous mechanical treatment (pmt) of iliac limb occlusion after endovascular aneurysm repair (evar).Ann vasc surg 2022 78: 161 through 169.

Event Description

Reported via journal article that within this study, it was reported that patient complications occurred.A meta analysis was performed to investigate the safety and efficacy of applying the angiojet ultra thrombectomy device in treating endograft occlusions in the iliac arteries following endovascular aneurysm repair (evar).This study utilized a retrospective analysis of 452 patients with infrarenal abdominal aortic aneurysm (aaa).Twelve of the patients experienced iliac limb occlusion during their follow- up period, and the 6f angiojet solent omni catheter was used in tandem with iliac angioplasty to treat these patients.Two patients developed gross hematuria following surgery and displayed hemoglobinuria, which in large amounts, increases kidney loads and leads to acute renal damage.The symptoms of one of the patients was alleviated a day later, while the other had mild to moderate renal dysfunction, with creatinine level being elevated from 61.3 micromole per liter before surgery to 124.1 micromole per liter following surgery.The patient was treated with intravenous administration of 5% sodium bicarbonate to alkalize their urine and dialysis, and was discharged a week later after creatinine level returned to normal.The repeated suction forces during the thrombectomy process had caused mechanical damage to the red blood cells, which led to intravascular hemolysis.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14734797
• MDR Text Key: 294540896
• Report Number: 2134265-2022-06198
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/17/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male