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

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

Patient Problem Injury (2348)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Bremer et al.(2020).Role of interventional radiologist in the management of acute pulmonary embolism.Seminars in interventional radiology vol.37, pages 62-73.Date of event was approximated using date of article submission.(b)(6).

Event Description

It was reported via journal article that patient complications occurred.A systematic review was performed on the use of catheter-directed thrombolysis (cdt) for the treatment of massive pulmonary embolism (pe).Meta-analysis showed pooled clinical success rate, defined as hemodynamic stabilization, resolution of hypoxia, and survival to discharge, was 86.5%, with higher clinical success rates seen in cases that used local thrombolytic therapy compared with mechanical thrombectomy alone.The pooled procedural complication rate was 7.9%, and major complication rate was 2.4%.The major complication rate was thought to be in large part due to the use of the rheolytic angiojet device, which caused 19 major complications, including 5 procedure-related deaths.

• 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: 10273440
• MDR Text Key: 198864527
• Report Number: 2134265-2020-09248
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2020

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: 06/24/2020
• Initial Date FDA Received: 07/14/2020
• 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