MAUDE Adverse Event Report: ANGIODYNAMICS, INC MINI STICK MAX-COAXIAL MICROINTRODUCER KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	45755
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a angiographic procedure, a micro guide wire end detached and a portion of the wire was identified as left in the pt.

• Brand Name: MINI STICK MAX-COAXIAL MICROINTRODUCER KIT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS, INC
• MDR Report Key: 12210755
• Report Number: MW5102699
• Device Sequence Number: 13783683
• Product Code: DRE
• UDI-Device Identifier: H965457550
• UDI-Public: H965457550
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 45755
• Device Catalogue Number: 45-755
• Device Lot Number: 5660526
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Weight: 98