MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; STAINLESS STEEL GUIDEWIRE

Model Number	M001201080
Health Effect - Clinical Codes	Death (1802); Foreign Body In Patient (2687)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Piece of guidewire broke off in pt.Per incident report: "while provider attempting to place nephrostomy tube using a guide wire," stainless steel" 7.5 cm broke part of the wire off inside the right kidney.Md attempted to snare wire with no success.Pt expired on (b)(6) 2020.Code was stopped at 2047 per nursing documentation.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: STAINLESS STEEL GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC ; spencer IN
• MDR Report Key: 11019023
• Report Number: 11019023
• Device Sequence Number: 11403142
• Product Code: DQX
• UDI-Device Identifier: 08714729735144
• UDI-Public: 08714729735144
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020
• Report Date (Section F): 12/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: M001201080
• Device Catalogue Number: M001201080
• Device Lot Number: 26100431
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2020
• 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: 74 YR
• Patient Weight: 73