MAUDE Adverse Event Report: ANGIODYNAMICS, INC SMARTPORT PLASTIC; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number CT80LPPDVI

Patient Problem Stroke/CVA (1770)

Event Date 11/12/2023

Event Type  malfunction  

Event Description

During a stroke, opened a 4.0mm spiderwire 320/190cm to prep for distal protection.Brought the filter back into the green housing underwater to prevent air bubbles in the filter basket, everything seemed to have gone back smoothly.Went to advance the filter wire into the sheath and up into the patient when the doctor noticed that it was not advancing smoothly anymore, removed the filter wire and sheath housing from the patient.When examining the filter wire, noticed that the wire poked through the sheath housing and was defective.There was no patient harm.A new filter wire was opened and prepped in the same way and advanced smoothly and the case continued.

• Brand Name: SMARTPORT PLASTIC
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 18191285
• MDR Text Key: 328795473
• Report Number: 18191285
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT80LPPDVI
• Device Lot Number: B607192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male