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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 Fracture (1260); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product. Device evaluated by manufacturer: returned product consisted of an agent drug coated balloon catheter. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined, which revealed multiple kinks along the hypotube. The hypotube is separated 35. 2cm from the hub. There is blood present on the balloon folds. The balloon is tightly folded.
 
Event Description
Reportable based on the product analysis completed on june 12, 2019. It was reported that a kink in the shaft and difficulty advancing occurred. A 2. 50 mm x 15. 00 mm agent balloon was advanced to the mildly calcified and mildly tortuous target lesion. During advancing the agent, it was noticed that the shaft was very soft, very kinked, and almost impossible to advance. The procedure was completed with another of the same device with no issues. No patient complications were reported in relation to this event. However, returned device analysis revealed a separation of the shaft. It was later reported the shaft broke during 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 Key8773017
MDR Text Key150558498
Report Number2134265-2019-07743
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 07/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2020
Device Model Number3825
Device Catalogue Number3825
Device Lot Number6664H18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2018
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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