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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3825
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Vascular Dissection (3160)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
Agent dcb registry it was reported that a dissection occurred. On (b)(6) 2021, the subject presented with unstable angina and the index procedure was performed on the same day. The 86% stenosed target lesion was located in the distal left anterior descending artery (lad) and was 10mm long, with a reference vessel diameter of 2. 25mm. The lesion was treated with predilation with a 2. 25mm x 12mm balloon, followed by treatment with a 2. 25mm x 15mm agent dcb and 2. 00mm x 20mm agent dcb. While treating the target lesion with the second agent dcb balloon, a grade b dissection was noted. The dissection was treated with an unknown intervention. Post procedurally, 30% residual stenosis was noted. Post dilation was not performed. On (b)(6) 2021, the subject was discharged on clopidogrel.
 
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Brand NameAGENT
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM 52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12477973
MDR Text Key271662177
Report Number2134265-2021-11643
Device Sequence Number1
Product Code LOX
Combination Product (y/n)Y
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3825
Device Catalogue Number3825
Device Lot Number04070H20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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