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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that a shaft break had occurred.A percutaneous coronary intervention was being performed.The 3.00mm x 20.00mm agent drug-coated balloon had apparently snapped while inside the patient and needed to be pulled out.The procedure was successfully completed with a different agent balloon without further issue.
 
Manufacturer Narrative
Device is a combination product.Device returned to manufacturer: the agent balloon was returned and analysis was completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 45.9cm from the hub.There are multiple kinks along the hypotube.There is blood present in the guidewire lumen and contrast present in the inflation lumen and the balloon is still tightly folded.
 
Event Description
It was reported that a shaft break had occurred.A percutaneous coronary intervention was being performed.The 3.00mm x 20.00mm agent drug-coated balloon had apparently snapped while inside the patient and needed to be pulled out.The procedure was successfully completed with a different agent balloon without further issue.
 
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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 Key8781107
MDR Text Key150719824
Report Number2134265-2019-07737
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2020
Device Model Number3825
Device Catalogue Number3825
Device Lot Number9755H18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Date Manufacturer Received07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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