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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 Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred. A percutaneous coronary intervention was performed on an 80% stenosed, 4. 00mm x30mm, eccentric, in stent restenosed, target lesion with a greater than 45 degree and less than 90 degree bend was located in the moderately tortuous and moderately calcified left anterior descending artery (lad). A 4. 00mm x 30. 00mm agent dcb balloon was advanced to the target lesion, but significant resistance occurred while operating the device. The balloon was inflated to 8 atmospheres, but the balloon ruptured. The device was removed and it was noticed that the balloon was leaking. The procedure was completed with another of the same device. No patient complications resulted and the patient was reported to be stable following the procedure.
 
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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 Key12196141
MDR Text Key262435570
Report Number2134265-2021-09246
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3825
Device Catalogue Number3825
Device Lot Number05606H20
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 Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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