MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET; CATHETER, CORONARY, ATHERECTOMY

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

Patient Problems Hematoma (1884); Vasoconstriction (2126); Hematuria (2558); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

Date of event estimated using date journal article was published.Initial reporter facility name: department of interventional and vascular radiology, nanjing first hospital, nanjing medical university.Gong, m., he, x., zhao, b.Et al.Endovascular revascularization strategies using catheter-based thrombectomy versus conventional catheter-directed thrombolysis for acute limb ischemia.Thrombosis j 19, 96 (2021).Https://doi.Org/10.1186/s12959-021-00349-9.

Event Description

It was reported via journal article that patient complications occurred.The aim of this study was to compare the safety and effectiveness of thrombectomy approaches via either catheter-based thrombectomy (cbt) or catheter-directed thrombolysis (cdt).A total of 98 patients (mean age 69.7 years, 60 male) who underwent endovascular intervention for alifrom january 2015 to july 2019 were included.Of these, 57 were treated with primary cbt via a large-bore catheter, an angiojet catheter or rotarex catheter, and/or underwent low-dose cdt, and 41 were treated with primary cdt.The safety and effectiveness of cbt compared to conventional cdt and other various endovascular techniques were evaluated.The 30-day complications were recorded.In angiojet cases, there were 3 instances of procedure-related distal embolization, 1 major complication, and 1 minor complication.Patients who underwent primary cbt had slightly fewer complications than those who underwent primary cdt (p =.059), especially for minor complications (p =.036).Minor complications for the cbt group included vessel spasm (n = 3), dissection of the superficial femoral artery (n = 1), hematuria (n = 1) and hematoma of the puncture site (n = 1); the rate of complications was significantly lower than that for cdt.The major complication except for distal embolization of the cbt group was compartment syndrome (n=3) requiring surgery for calf fasciotomy.Cbt had a higher procedure-related distal embolization rate than those who underwent primary cdt (p =.009), in the subgroup analysis, rotarex catheters had more procedure-related distal emboli than large-bore catheters and angiojet catheters, yet the difference was not statistically significant among the 3 groups (p =.765).Owing to the small size of these vessels and underlying chronic disease, adjunctive cdts were performed, the dislodged thrombus was well treated without permanent sequelae.

• Brand Name: ANGIOJET
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14654244
• MDR Text Key: 293832687
• Report Number: 2134265-2022-06635
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2022

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
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/10/2022
• 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; Hospitalization