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

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Renal Failure (2041); Swelling (2091); Thrombosis (2100); Hematuria (2558)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Lichtenberg, michael k.W., et al.Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis, a systematic review and meta analysis.Vasa, 2020, pp.1:9., doi:10.1024/0301-1526/a000875.Date of event was approximated based on submission date of article.

Event Description

It was reported via journal article that patient complications occurred.A meta-analysis was performed to compare effectiveness and safety of percutaneous mechanical thrombectomy (pmt) and thrombolysis alone (thr) in patients with acute or subacute iliofemoral deep vein thrombosis (ifdvt).The angiojet thrombectomy system was a device referenced within the study.Acute kidney disease, renal dysfunction, major bleeding, hematuria, and post-thrombotic syndrome were noted to have occurred.Pain and swelling are associated with post-thrombotic syndrome.Recurrent iliofemoral deep vein thrombosis was also noted.

• 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
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10473480
• MDR Text Key: 205012877
• Report Number: 2134265-2020-12019
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/31/2020

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: 08/03/2020
• Initial Date FDA Received: 08/31/2020
• 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