MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO DURAMAX WITH ENDEXO TECHNOLOGY/CHRONIC HEMODIALYSIS CATHETER BASIC KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number 5567322

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Tunneled dialysis catheter sleeve stuck on catheter when pulling it through the tunneled track.Broke off inside patient, we were able to retrieve.Patient not harmed.

• Brand Name: BIOFLO DURAMAX WITH ENDEXO TECHNOLOGY/CHRONIC HEMODIALYSIS CATHETER BASIC KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 10918598
• MDR Text Key: 218918984
• Report Number: MW5098110
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5567322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR