MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC, ZEBRA GUIDEWIRE

Model Number	M0066701120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific product - zebra guidewire.Coating separated from wire during surgical procedure.Surgeon was able to retrieve coating, no harm to patient.Item ref # m0066701120, lot # 192711021, expiration date 05/17/2019.

• Brand Name: BOSTON SCIENTIFIC, ZEBRA GUIDEWIRE
• Common Device Name: ZEBRA GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6493003
• Report Number: MW5069082
• Device Sequence Number: 656059
• Product Code: EZB
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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: Health Professional
• Device Expiration Date: 05/17/2019
• Device Model Number: M0066701120
• Device Lot Number: 192711021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR