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

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

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Diniz j, coelho a, mansilha a.(2020) endovascular treatment of iliofemoral deep venous thrombosis: is there enough evidence to support it? a systematic review with meta-analysis.International angiology.Volume 39 (issue 2), pp.93-104.Date of event was approximated using date of article first publication.

Event Description

It was reported via journal article that patient complications occurred.Endovascular treatment of iliofemoral deep venous thrombosis data was reviewed for various techniques.Meta-analysis showed angiojet is an effective option for thrombus removal that may increase the efficiency of thrombus clearance and lower the necessary infusion dose and time for thrombolytic drugs to act.However, it may cause hemolysis, hemoglobinuria and vessel wall and valve damage.Bleeding was noted to have occurred.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10363594
• MDR Text Key: 201583429
• Report Number: 2134265-2020-10357
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 08/04/2020

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: 07/27/2020
• Initial Date FDA Received: 08/04/2020
• 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): Other