BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 2031941 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02073
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD VISIBLE AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH PRODUCT HANDLING DURING THE PROCEDURE. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS ALSO NOTED OFFSET AND OVERLAPPED INTERMEDIATE COILS SPORADICALLY 1 MM PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 7 MM WHICH IS CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. THERE WAS A BEND IN THE TIP 5 MM PROXIMAL TO THE TIP BALL WHICH IS CONSISTENT WITH INTERACTION WITH THE LESION AND/OR GUIDE WIRE TIP RE-SHAPING TECHNIQUE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE INDICATING THAT THIS DAMAGE WAS NOT LIKELY PRE-EXISTING. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS CORE VISIBLE IN THE HYPOTUBE AT THE SEPARATION. THE SEPARATED PORTION WAS RETURNED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND AND THERE WAS NO MECHANICAL DAMAGE OBSERVED ON THE CORE. IT WAS NOTED THAT THERE WAS CORE EXTENDING OUT THE HYPOTUBE, INDICATING THE HYPOTUBE WAS PROPERLY ATTACHED TO THE CORE. FOR THE WIRE TO FAIL IN THIS MANNER, THE HYPOTUBE BEING OVER PULLED OR OVER BENT WOULD REQUIRE IT TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCED TO CAUSE A SEPARATION. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN PRODUCTS CAN ALL BE FACTORS. THE LESION WAS DESCRIBED AS DIFFICULT, CALCIFIED AND STENOSED AT 80% WHICH COULD HAVE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. ALTHOUGH IT WAS REPORTED THAT THERE WAS NO RESISTANCE OR PRESSURE DURING HANDLING, IT IS POSSIBLE THAT THE GUIDE WIRE COULD HAVE BEEN BENT DURING MANIPULATION ADVANCING TO THE LESION AND LATER FRACTURED. BASED ON THE RETURNED PRODUCT ANALYSIS AND THE SEM ANALYSIS RESULTS, THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR GUIDE WIRE SEPARATION FOR THIS LOT. MANUFACTURING PERFORMS A NON DESTRUCTIVE HYPOTUBE JUNCTION PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BMW GUIDE WIRE WAS USED IN A DIFFICULT RIGHT CORONARY ARTERY WHICH WAS CALCIFIED AND STENOSED AT 80%. IT WAS USED TO PLACE A NON-ABBOTT BALLOON FOR PRE-DILATATION. THE PRE-DILATATION WAS COMPLETED, AND AFTER REMOVAL OF THE BALLOON, THE GUIDE WIRE WAS REMOVED TO RE-SHAPE THE DISTAL TIP. DURING TIP RE-SHAPE, THE GUIDE WIRE SEPARATED INTO 2 PIECES, 15 TO 20 CENTIMETERS FROM THE DISTAL TIP (ALL PARTS WERE OUTSIDE OF THE PATIENT). THERE WAS NO RESISTANCE OR PRESSURE NOTED DURING USE IN THE PATIENT OR DURING HANDLING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE WIRE WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-TEMECULA-CT 0081771

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR DIL CATH: RYUJIN 2.5 X 20GUIDE CATH: JR4 5F