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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 Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/30/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred.A 018/260 platinum plus guide catheter was advanced.However, it was noted that the wire broke off inside the patient.The remaining piece of the guide wire was able to be removed without patient injury.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
 
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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 Key7919179
Report Number2134265-2018-61344
Device Sequence Number1449303
Product Code DQX
UDI-Device Identifier08714729114574
UDI-Public08714729114574
Combination Product (Y/N)N
Initial Reporter StateOH
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 Physician
Type of Report Initial
Report Date (Section B) 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/21/2021
Device Model Number39935
Device Catalogue Number39935
Device Lot Number0022153309
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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