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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.
 
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.It was further reported that the balloon was inflated once.There was no intervention performed to remove the balloon.It was noted that the balloon was removed directly.
 
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Brand Name
AGENT
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12196141
MDR Text Key262435570
Report Number2134265-2021-09246
Device Sequence Number1
Product Code LOX
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date08/05/2022
Device Model Number3825
Device Catalogue Number3825
Device Lot Number05606H20
Was Device Available for Evaluation? No
Date Manufacturer Received07/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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