MAUDE Adverse Event Report: BOSTON SCIENTIFIC ACCU-STICK II W/RO MARKER INTRODUCER SYSTEM WITH J-TIP WIRE IN, 0.018

Model Number	M001207020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Micro-wire tip sheared during attempted percutaneous nephrostomy.

• Brand Name: ACCU-STICK II W/RO MARKER INTRODUCER SYSTEM WITH J-TIP WIRE IN, 0.018
• Common Device Name: ACCU-STICK II W/RO MARKER INTRODUCER SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6269630
• Report Number: MW5067388
• Device Sequence Number: 1003913
• Product Code: DQO
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: No Information
• Device Model Number: M001207020
• Device Lot Number: 19878615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR