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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); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred. Vascular access was obtained via a right artery. The 80% stenosed, 3. 0 x 30mm, eccentric, in stent restenosed target lesion with a greater than 45 degree bend and less than 90 degree bend, was located in the moderately tortuous and moderately calcified right coronary artery (rca). A 3. 00 x 30. 00mm agent drug coated balloon (dcb) was selected for treatment. While advancing the agent dcb balloon, significant resistance was encountered. While inflating the balloon at 8 atmospheres, a balloon rupture occurred. The device was removed from the patient, and it was noticed that the balloon was leaking. The procedure was completed with another of the same device. No patient complications resulted in relation to this event, 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 Key12538384
MDR Text Key273544628
Report Number2134265-2021-11535
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
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3825
Device Catalogue Number3825
Device Lot Number06260H20
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 Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2020
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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