MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SOFT-VU ANGIOGRAPHIC CATHETER PIGTAIL 4F (1.4MM X 100); CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UPN H787107071030

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

While md was using the catheter, he was unable to pass the wire over it and had difficulty removing it from the patient.When the catheter was removed from the pt, it was noted to be all twisted in the midsection.Fda safety report id # (b)(4).

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER PIGTAIL 4F (1.4MM X 100)
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 11194679
• MDR Text Key: 227986939
• Report Number: MW5098865
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/13/2021

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 Expiration Date: 04/30/2022
• Device Catalogue Number: UPN H787107071030
• Device Lot Number: 5458863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2021
• 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: 51 YR