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

Model Number	45756
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During cardiac cath for stemi, angiodynamics mini stick max coaxial microintroducer kit used, sheath 5fx10cm, needle 70 mm echogenic, wire nitinol tungsten, ref 45-756, lot 5561860, upn (b)(4), exp 12/31/2022 used.Pt moved during the procedure and when cardiologist tried to remove wire, it became entrapped in the vessel and its fragment was dislodged in subintimal space of external iliac artery.Cardiologist unable to remove fragment.When the wire removed (the remaining wire not the fragment), it was noted the wire had became unraveled and "looked like a spring".Vascular surgery consulted regarding extraction of entrapped wire fragment, however, open surgery for retrieval not indicated.Per vascular surgeon, wire fragment is subintimal and therefore unlikely to represent an embolic source or nidus.Covered stent to the area considered but determined not to be needed.Full disclosure to family.Fda safety report id# (b)(4).

• Brand Name: COAXIAL MICROINTRODUCER KIT MINI STICK MAX
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS, INC. / NAVILYST MEDICAL, INC.
• MDR Report Key: 9840252
• Report Number: MW5093777
• Device Sequence Number: 2373172
• Product Code: DRE
• UDI-Device Identifier: H965457560
• UDI-Public: H965457560
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 45756
• Device Catalogue Number: 45-756
• Device Lot Number: 5561860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• 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: Other
• Patient Age: 43 YR
• Patient Weight: 115