BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE¿

    MDR report key: 7343897 · Received March 15, 2018

    Report

    Report Number
    2134265-2018-01826
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 17, 2018
    Report Date
    February 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPN - SEARCH UPDATED FROM H74912130010 - MODEL-LUGE SINGLE 182CM - 12130-01 TO H74912130012 - LUGE 182CM (5PK) - 12130-01. UPN UPDATED FROM H74912130010 TO H74912130012. DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.: UNIT RETURNED IN A GENERIC PLASTIC BAG. THE UNIT RETURNED HAS WIRE BROKEN, AS PART OF OVERALL VISUAL REVISION. THE DEVICE HAS THE DISTAL TIP (SPRING) DETACHED FROM THE BODY, THE DETACHED SECTION STARTS APPROXIMATELY AT 179 CM FROM THE PROXIMAL END; THE SPRING TIP RETURNED TOGETHER WITH THE GUIDEWIRE IS KINKED AND STRETCHED. BESIDES, THE BODY IS KINKED APPROXIMATELY AT 0,7 CM FROM THE PROXIMAL END AND THE SECTION OF WIRE LOCATED NEAR THE DETACHED SECTION IS ALSO KINKED. NO MORE DAMAGES WERE FOUND IN THE DEVICE. OVERALL LENGTH AND OUTER DIAMETER (OD) OF DISTAL TIP COULD NOT BE PERFORMED DUE TO DEVICE CONDITION (DISTAL TIP DETACHED). OD OF MIDDLE AND PROXIMAL SECTION OF THE DEVICE WERE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE LOT INFORMATION: THE SPECIFIC DEVICE LOT NUMBER IS NOT KNOWN, HOWEVER, IT WAS INDICATED THAT THE AFFECTED LUGE¿ LOT # WAS ONE OF THESE TWO: 21317059 - MANUFACTURED DATE 10/30/2017; EXPIRATION DATE 1/30/2019; 21499874 - MANUFACTURED DATE 12/11/2017; EXPIRATION DATE 12/11/2019. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 182CM LUGE¿ GUIDE WIRE WAS ADVANCED INTO THE POSTERIOR DESCENDING BRANCH OF THE RCA AND A SECOND LUGE¿ GUIDE WIRE WAS ALSO ADVANCED TO WIRE ANOTHER BRANCH OF THE RCA. AT THE END OF HE PROCEDURE, DILATATION AND STENTING WAS PERFORMED IN THE DISTAL RCA; HOWEVER, UPON REMOVING THE GUIDE WIRE IN THE DISTAL RCA, THE TIP OF THE WIRE GOT DETACHED INSIDE THE ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP BY SNARING AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 182CM LUGE¿ GUIDE WIRE WAS ADVANCED INTO THE POSTERIOR DESCENDING BRANCH OF THE RCA AND A SECOND LUGE¿ GUIDE WIRE WAS ALSO ADVANCED TO WIRE ANOTHER BRANCH OF THE RCA. AT THE END OF HE PROCEDURE, DILATATION AND STENTING WAS PERFORMED IN THE DISTAL RCA; HOWEVER, UPON REMOVING THE GUIDE WIRE IN THE DISTAL RCA, THE TIP OF THE WIRE GOT DETACHED INSIDE THE ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP BY SNARING AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186219 LUGE¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74912130012

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention