MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS; WIRE, GUIDE, CATHETER

Model Number	06597051
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ccl [cardiac catheterization lab] team arrived.During rfv [right femoral vein] temporary pacer placement, mini stick wire knotted and trapped broke off into rfv.Rn contacted [redacted] md on call.Per staff, contact vascular.Rn [redacted] contacted md to come and perform a surgical cutdown to remove wire.All md's are aware.Or team arrived for cutdown, case details in charting.Patient underwent a vascular cutdown for knotted wire stuck in groin under local lido and moderate sedation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 22564032
• Report Number: 22564032
• Device Sequence Number: 18478618
• Product Code: DQX
• UDI-Device Identifier: 15051684012683
• UDI-Public: (01)15051684012683
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2025
• Report Date (Section F): 07/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: 06597051
• Device Lot Number: 5846810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Date Report Sent to FDA: 07/18/2025