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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 39935
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/18/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a coating issue occurred.The stenosed target lesion was located in the artery in the groin.A 018/180 platinum plus guidewire was advanced.However, when they put the wire through an introducer, the coating of the wire started shredding off.The procedure was completed with another of the same device.There were no patient complications reported and the patient is fine.
 
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Brand Name
PLATINUM PLUS
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8492284
Report Number2134265-2019-03597
Device Sequence Number1576036
Product Code DQX
UDI-Device Identifier08714729114567
UDI-Public08714729114567
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K935997
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/08/2019
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 Date05/13/2021
Device Model Number39935
Device Catalogue Number39935
Device Lot Number0022117737
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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