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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 2749
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/20/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the tip was fractured.The target lesion was located in the right coronary artery.A 300cm j luge guidewire was selected for use.The lesion was successfully treated.However, the wire was fractured at the distal tip upon removal from the lesion.The wire was removed in one piece, but was observed to be fractured.The procedure was completed with another wire.There were no patient complications reported.
 
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Brand Name
LUGE
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9898317
Report Number2134265-2020-04074
Device Sequence Number11366662
Product Code DQX
UDI-Device Identifier08714729252214
UDI-Public08714729252214
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K143587
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) 03/30/2020
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 Date07/01/2021
Device Model Number2749
Device Catalogue Number2749
Device Lot Number0024050359
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/23/2020
Initial Report FDA Received Date03/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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