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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. MAGIC TORQUE DLVR; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. MAGIC TORQUE DLVR; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 1013-02
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/10/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that guidewire coating fray encountered.The 100% stenosed target lesion was located in the non tortuous superficial femoral artery.A gw/.035/315 (bx/3) magic torque dlvr guidewire was used for treatment.However, during procedure, the back end of the wire coating was frayed upon removing the angiojet catheter.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
MAGIC TORQUE DLVR
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
MDR Report Key9220293
Report Number2134265-2019-12795
Device Sequence Number2145549
Product Code DQX
UDI-Device Identifier08714729982906
UDI-Public08714729982906
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
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) 10/22/2019
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 Date10/07/2021
Device Model Number1013-02
Device Catalogue Number1013-02
Device Lot Number0022763610
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/10/2019
Initial Report FDA Received Date10/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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