BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 1013271 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00186
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE GUIDE WIRE RETURNED WITHOUT BLOOD OR CONTRAST VISIBLE. THERE WAS A BEND ON THE SHAPING RIBBON, 1.7 CM PROXIMAL TO THE TIPBALL. THERE WAS NO STRETCHED TIP COILS NOTED. THE GUIDE WIRE WAS RETURNED WITH THE SEPARATION OF THE CORE, 35.5 CM PROXIMAL TO THE PROXIMAL SOLDER. THE CORE SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS A CORE VISIBLE IN THE HYPOTUBE AT THE SEPARATED DISTAL END. THE FRACTURE FACE WAS OVALED. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE DISTAL END OF THE SEPARATED GUIDE WIRE AND THE PROXIMAL END WERE PASSED THROUGH A HOLE AND MET MFG CRITERIA. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRONIC MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED DEVICE. REVIEWING THE SEM RESULT, THE DEVICE CORE FAILED FROM TENSILE OVERLOAD. THERE WERE SOME AREAS OF FATIGUE AROUND THE THE EDGES OF THE FRACTURE SITE THAT MAY HAVE HELPED INITIATE THE FRACTURE. THE FATIGUE MAY HAVE BEEN THE RESULT OF OVERBENDING DURING THE RENALIS PROCEDURE, AND THEN IF THE GUIDE WIRE MET RESISTANCE DUE TO BEING STUCK IN THE PLAQUE AS REPORTED, THIS WOULD ACCOUNT FOR THE TENSILE OVERLOAD. THE GUIDE WIRE WAS THEREFORE SUBJECTED TO FORCES THAT EXCEEDED THE STRENGTH OF THE DEVICE. IN THIS CASE, THE FAILURE APPEARS TO BE RELATED TO CASE CONDITIONS. THE GUIDE WIRE TIP BENDING FOUND IN THE ANALYSIS APPEARS TO BE THE RESULT OF THE APPLICATION OF THE "J" SHAPE REQUIRED FOR THE PROCEDURE AND WAS NOT A QUALITY ISSUE WITH THE GUIDE WIRE. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. MFG 100% CHECKS ALL GUIDE WIRE FOR ANY BENDS OR KINKS ALONG THE CORE. EVERY GUIDE WIRE IS NON-DESTRUCTIVELY CHECKED FOR HYPOTUBE JOINT TENSILE STRENGTH AND MUST MEET THE MINIMUM 2 POUND SPEC REQUIREMENT. ALSO, ON A SAMPLING BASIS, THE HYPOTUBE JOINT IS PULL TESTED TO FAILURE AND MUST MEET CONTROL REQUIREMENTS SHOWING THAT THE LOT IS IN CONTROL AND MEETS THE SPEC FOR PULL TEST. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING USE OF THE GUIDE WIRE IN A RENALIS PROCEDURE, THE TIP ROTATED WELL AT FIRST; HOWEVER, LATER, THE TIP DID NOT ROTATE WELL. IT WAS THOUGHT THAT THE GUIDE WIRE BECAME STUCK IN PLAQUE IN THE VESSEL. THE GUIDE WIRE AND GUIDING CATHETER WERE REMOVED TOGETHER AND AT THE TIME OF THE REMOVAL, THE GUIDE WIRE WAS INTACT, BUT WAS STRETCHED. IT WAS AFTER REMOVAL FROM THE PT, AND DURING REMOVAL OF THE GUIDE WIRE FROM THE GUIDING CATHETER, THAT THE GUIDE WIRE BECAME SEPARATED. ANOTHER ATTEMPT WAS MADE WITH A DIFFERENT GUIDE WIRE, BUT THE PROCEDURE WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7011871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK