MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIODYNAMIC MICRO-INTRODUCER; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 06597022

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

Patient underwent routine pre-transplant heart cath with biopsy- while attempting to obtain access in the (r) femoral vein, the micro- introducer wire become lodged in the soft tissue of the group.While attempting to remove the wire, the distal tip (< 2mm) of the wire was dislodged.The wire was not flow- limiting and retrieval was not attempted.

• Brand Name: ANGIODYNAMIC MICRO-INTRODUCER
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS, INC; queensbury NY
• MDR Report Key: 11273390
• MDR Text Key: 230702096
• Report Number: MW5099201
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 06597022
• Device Lot Number: 5645484
• Is the Reporter a Health Professional?: Yes
• 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: 59 YR