MAUDE Adverse Event Report: ANGIODYNAMICS INC. SINGLE LUMEN STANDARD TITANIUM PORT 8 FRENCH SMART PORT - VORTEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number UPN - H787CT805STDVI1

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Patient diagnosed with ewing sarcoma and had a single lumen left subclavian porta cath placement on (b)(6) 2019.Portacath no longer needed and was removed on (b)(6) 2020.Patient relapsed and required reinsertion of a portacath on (b)(6) 2022 at which time an old blue catheter 1cm long from prior port was discovered and removed.No harm to patient.The surgeon identified the blue catheter found via catalog comparison as a blue boot strain relief mechanism that was on the catheter placed originally on (b)(6) 2019.Catalog # ct80stpd-vi, lot # 5369245.Fda safety report id# (b)(4).

• Brand Name: SINGLE LUMEN STANDARD TITANIUM PORT 8 FRENCH SMART PORT - VORTEX
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS INC.
• MDR Report Key: 14194087
• MDR Text Key: 290063060
• Report Number: MW5109288
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• 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: 04/20/2022

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: 07/31/2021
• Device Model Number: UPN - H787CT805STDVI1
• Device Catalogue Number: CT80STPD-VI
• Device Lot Number: 5369245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White