BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1933464 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02834
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 26, 2010
    Manufacturer
    AV-BARCELONETA
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE GUIDE WIRE WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS DRIED CONTRAST VISIBLE ON THE CORE AND COILS. THE REPORTED SEPARATION WAS CONFIRMED. THE HYPOTUBE HAD SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THERE WAS A SMALL PORTION OF CORE EXTENDING OUT OF THE HYPOTUBE. THERE WAS A BEND IN THE HYPOTUBE 2CM PROXIMAL TO THE PROXIMAL END OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS SUGGESTED THAT THE CORE FAILURE MAY BE ATTRIBUTED TO A DUCTILE OVERLOAD AT A BEND. TYPICALLY A DUCTILE OVERLOAD AT A BEND SUGGESTS THAT THE CORE INITIALLY KINKED IN THIS AREA AND WITH ADDITIONAL MOVEMENT, ULTIMATELY SEPARATED. THE JOINT AREA WHICH TRANSITIONS FROM THE CORE TO THE HYPOTUBE MAY BE MORE VULNERABLE TO SEPARATION IF FORCE IS APPLIED ONCE KINKED. IN THIS CASE, IT IS LIKELY THAT THE CORE SEPARATION INITIATED FROM A KINK, POSSIBLY DUE TO EXCHANGING THE INTRODUCER SHEATH AGAINST RESISTANCE. ADDITIONALLY, THE BEND NOTED 2CM PROXIMAL TO THE PROXIMAL END OF THE HYPOTUBE MAY HAVE LIKELY BEEN INDUCED DURING USE AS THERE WAS NO DAMAGE TO THE TIP NOTED PRIOR TO USE, SUGGESTING THAT THE DAMAGE WAS NOT PRE-EXISTING. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. BECAUSE OF THE SEPARATION, THE DISTAL SEPARATED PORTION OF THE GUIDE WIRE HAD TO BE SURGICALLY REMOVED WHICH PROLONGED THE PROCEDURE. REPORTEDLY, THE GUIDE WIRE WAS BEING USED IN THE RENAL ARTERY. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THAT: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE USE OF THE GUIDE WIRE IN THE RENAL ARTERY CAUSED OR CONTRIBUTED TO THE REPORTED SEPARATION. THE CORE SEPARATION AND SUBSEQUENT DAMAGE TO THE GUIDE WIRE APPEAR TO BE RELATED TO CASE CIRCUMSTANCES, AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. MANUFACTURING INSPECTS 100% OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) (INDICATION FOR USE). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE CALCIFIED AND TORTUOUS RIGHT RENAL ARTERY, WHILE EXCHANGING THE INTRODUCER SHEATH FROM A 5F TO 6F, SLIGHT RESISTANCE WAS FELT AND THE BALANCE MIDDLEWEIGHT GUIDE WIRE SEPARATED INTO TWO PIECES AT THE INGUINAL LEVEL. THE GUIDE WIRE WAS SURGICALLY REMOVED. DILATATION HAS BEEN RESCHEDULED FOR A LATER UNSPECIFIED DATE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER HAS NO POWER. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-BARCELONETA 9071471

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention INTRODUCER SHEATH: 5FR, 6FR