MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; SENSOR WIRE

Model Number 08714729376361

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  malfunction  

Event Description

Pt had a right ureteral stent replaced.When sensor wire was removed from pt, the wire was frayed.There was no pt harm and the surgeon was experienced in this work, but all were surprised the wire frayed.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: SENSOR WIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; el coyol, alajuela, cr ; CS
• MDR Report Key: 6844719
• MDR Text Key: 85113077
• Report Number: MW5071967
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729376361
• UDI-Public: 08714729376361
• Combination Product (y/n): N
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: 08714729376361
• Device Catalogue Number: M0066703080
• Device Lot Number: 20799651
• 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: 93 YR