BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE.035 SELF EXPANDING STENT SYSTEM

    MDR report key: 801152 · Received December 13, 2006

    Report

    Report Number
    3004742046-2006-00519
    Event Type
    Malfunction
    Date Received
    December 13, 2006
    Date of Event
    November 29, 2006
    Report Date
    November 29, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K021824
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND ABSOLUTE .035 PART# 1010558-40, LOT# 6101351, REFERENCED IN B5 AND D11 IS BEING FILED UNDER THE SAME MANUFACTURER REPORT NUMBER. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS OF THE FIRST RETURNED UNIT REVEALED THAT THE ABSOLUTE CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE SHAFT. THE STENT WAS DEPLOYED AND NOT RETURNED. THE DISTAL OUTER MEMBER WAS RETRACTED 1.0 CM PROXIMAL TO THE PROXIMAL END OF THE TIP. THERE WERE TWO KINKS IN THE SHAFT THAT PENETRATED THROUGH THE OUTER MEMBER AND INNER BRAIDED MEMBER; 0.1 CM AND 44.8 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE CHATTER MARKS ON THE SHAFT 54.0 CM DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 23.0 CM. THERE WAS NO OTHER DAMAGE NOTED ON THE CATHETER. THE HANDLE WAS IN THE UNLOCKED POSITION. UPON OPENING THE HANDLE, THE RACK WAS IN THE DISTAL POSITION AND PARTIALLY RETRACTED 1.4 CM. THE THUMBWHEEL COULD BE ROTATED IN THE CLOCKWISE DIRECTION AS NORMAL AND NOT COUNTER CLOCKWISE. THERE WAS BLOOD VISIBILITY INSIDE THE HANDLE. ALL THE INTERNAL MECHANISMS WERE INTACT. QUALITY ASSURANCE ANALYSIS OF THE SECOND RETURNED UNIT REVEALED THAT THE ABSOLUTE CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE SHAFT. THERE WAS BLOOD VISIBLE ON THE HANDLE. THE STENT WAS DEPLOYED AND NOT RETURNED. THE DISTAL OUTER MEMBER WAS RETRACTED. THERE WERE TWO KINKS IN THE SHAFT 0.2 CM AND 42.3 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A SEVERE KINK IN THE INNER BRAIDED MEMBER 70.0 CM DISTAL TO THE STRAIN RELIEF TUBING. THE KINK CAUSED THE INNER BRAIDED MEMBER TO PARTIALLY SEPARATE DURING HANDLING. THERE WAS A KINK IN THE STENT HOLDER 3.5 CM PROXIMAL TO THE TIP. THERE WERE CHATTER MARKS IN THE SHAFT 53.5 CM DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 21.1 CM. THERE WAS NO OTHER DAMAGE NOTED ON THE CATHETER. THE HANDLE WAS IN THE UNLOCKED POSITION. UPON OPENING THE HANDLE, THE RACK WAS FULLY RETRACTED IN THE PROXIMAL POSITION. THERE WAS BLOOD VISIBLE INSIDE THE HANDLE. ALL THE INTERNAL MECHANISMS WERE INTACT. THE RACK WAS REPOSITIONED DISTALLY IN THE HANDLE AND THE THUMBWHEEL ROTATED AND RETRACTED THE DISTAL SHEATH WITHOUT RESISTANCE. QUALITY ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE. ALL CATHETER SHAFTS ARE 100% INSPECTED FOR SHAFT DAMAGE AND ALL CATHETERS ARE 100% INSPECTED FOR THUMBWHEEL ROTATION AND RETRACTABLE SHEATH MOVEMENT. THERE WAS NO MENTION FROM THE ACCOUNT DURING PREP INDICATING ANY KINKS WERE OBSERVED, SO IT IS BELIEVED THAT THE DAMAGE OCCURRED DURING USE. THIS IS NOT A MANUFACTURING QUALITY ISSUE. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE DEPLOYMENT, FAILURE TO RETRACT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING THE STENTING PROCEDURE OF THE SFA (SUPERFICIAL FEMORAL ARTERY), THE PHYSICIAN IMPLANTED AN EXCEED STENT SUCCESSFULLY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE ABSOLUTE; HOWEVER, WHILE GOING OVER THE ARCH, THE THUMBWHEEL LOCKED UP AND THE PHYSICIAN WAS UNABLE TO PROCEED. THE PHYSICIAN REMOVED THE DEVICE BUT UPON REMOVAL, THE STENT FELL OFF OF THE DEVICE OUTSIDE OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO ADVANCE A SECOND ABSOLUTE; HOWEVER, THE THUMBWHEEL LOCKED UP AND UPON REMOVAL FROM THE PATIENT, THE STENT FELL OFF OUTSIDE OF THE PATIENT. THE PHYSICIAN THEN IMPLANTED A SECOND EXCEED STENT SUCCESSFULLY. THERE WERE NO PATIENT EFFECTS AND NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE.035 SELF EXPANDING STENT SYSTEM 78FGE FGE GUIDANT ENDOVASCULAR SOLUTIONS NA 6101351

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR ABSOLUTE| STENT: EXCEED (2)| DIL CATH: AGILTRAC 6X60