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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 Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/10/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left anterior descending artery.A 300cm (5 pk) luge wire was used in a procedure.However, at the end of the case, just after post-dilatation with nc quantum apex balloon, it was noticed that the wire tip broke and dislodged inside the body.The tip was then successfully snared out from the patient's body.No further patient complications were reported and the patient was fine.
 
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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 Key8032882
Report Number2134265-2018-62548
Device Sequence Number1303267
Product Code DQX
UDI-Device Identifier08714729252207
UDI-Public08714729252207
Combination Product (Y/N)N
Initial Reporter StateTX
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) 11/02/2018
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 Date07/15/2020
Device Model Number2749
Device Catalogue Number2749
Device Lot Number0022381007
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date11/02/2018
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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