MAUDE Adverse Event Report: BOSTON SCIENTIFIC PLATINUM PLUS; GUIDE WIRE

Catalog Number	M001467310
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Removed 0.18 platinum plus wire from packaging to find floppy tip of wire had become unwound and appeared to be on the verge of breaking.Wire was removed from service and was not used on the patient.

• Brand Name: PLATINUM PLUS
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; el coyol, alajuela cr
• MDR Report Key: 7395587
• Report Number: MW5076317
• Device Sequence Number: 1393011
• Product Code: DQX
• UDI-Device Identifier: 08714729326205
• UDI-Public: 08714729326205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 04/02/2018

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: 11/27/2020
• Device Catalogue Number: M001467310
• Device Lot Number: 21443300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR