MAUDE Adverse Event Report: NAVILYST MEDICAL, INC. ANGIODYNAMICS MINI STICK MAX; MINISTICK MAX

Catalog Number	45-759
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
During attempted peripheral artery angioplasty of left femoral artery, was accessed utilizing the micropuncture technique.It was difficult to place the micropuncture sheath over the guidewire into vessel.The guidewire actually broke with part being retained in the iliac artery.The common femoral artery was re-accessed by gaining entry into the vessel.A 4-french angled glide catheter and a 2mm micro snare kit was used to retrieve the broken wire.There were no complications as a result of this event.

• Brand Name: ANGIODYNAMICS MINI STICK MAX
• Common Device Name: MINISTICK MAX
• Manufacturer (Section D): NAVILYST MEDICAL, INC.
• MDR Report Key: 5952310
• Report Number: MW5064763
• Device Sequence Number: 1916396
• Product Code: DRE
• UDI-Device Identifier: H965457590
• UDI-Public: H965457590
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 45-759
• Device Lot Number: 5061463
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 66