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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ACCUVU CATHETER,INTRAVASCULAR, DIAGNOSTIC

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ANGIODYNAMICS, INC. ACCUVU CATHETER,INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 13709703
Device Problems Hole In Material (1293); Failure to Deliver (2338); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2017
Event Type  malfunction  
Event Description
The omni flush catheter was place over a glide wire. The glide wire was removed for injection of contrast via power injector for visualization. The injection was not completed after three attempts. The omni flush catheter found with large defect; tear or large hole in catheter, thus making it unable to deliver the contrast to the end of the catheter.
 
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Brand NameACCUVU
Type of DeviceCATHETER,INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury NY 12804
MDR Report Key6813604
MDR Text Key83360952
Report Number6813604
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number13709703
Device Lot Number5200753
Other Device ID Number5FR X 100CM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2017
Event Location Hospital
Date Report to Manufacturer07/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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