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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 Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product. Device returned to manufacturer: the agent drug-coated balloon was received and analysis was completed. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed that the tip was separated and did not return for analysis. The location of separation appears to have been stretched. Microscopic examination revealed buckling to the guidewire lumen approximately 17mm from the separation and is approximately 9mm long. The balloon is deformed at the buckling section. The guidewire lumen is stretched 64mm from the separation. There is a hole in the guidewire lumen 65mm from the separation and it appears to have been made by a guidewire puncturing it. Product analysis confirmed that the damage found to the device would have caused difficulty to load or track a wire.
 
Event Description
Reportable based on analysis completed 10 sept 2019. It was reported that the 2. 00 x 30. 00mm agent drug-coated balloon could not be placed on the guidewire. The physician believed that the tip of the balloon catheter was deformed. The physician completed the procedure with another of the same device without any problems or patient harm. When the balloon was received for analysis it was discovered that the tip was separated from the rest of the device.
 
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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 Key9140212
MDR Text Key160728807
Report Number2134265-2019-11596
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2020
Device Model Number3825
Device Catalogue Number3825
Device Lot Number10448H18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2018
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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