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

Model Number M0066701120

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2017

Event Type  malfunction  

Event 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
• Type of Device: ZEBRA GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6493003
• MDR Text Key: 72921836
• Report Number: MW5069082
• Device Sequence Number: 1
• Product Code: EZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR