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

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.

• Brand Name: ACCUVU
• Type of Device: CATHETER,INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• MDR Report Key: 6813604
• MDR Text Key: 83360952
• Report Number: 6813604
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 13709703
• Device Lot Number: 5200753
• Other Device ID Number: 5FR X 100CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR