BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI- TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1071784 · Received July 7, 2008

    Report

    Report Number
    2024168-2008-00551
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 9, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THE SHAPING RIBBON WAS SEPARATED 2.1 CM DISTAL TO THE CENTER SOLDER. THE SEPARATED PORTION OF THE SHAPING RIBBON WAS STILL ATTACHED TO THE TIPBALL. THERE WAS APPROXIMATELY 9 MM OF SHAPING RIBBON ATTACHED TO THE TIPBALL. THE CORE WAS STILL INTACT. THE TIP COILS WERE STRETCHED DISTAL TO THE CENTER SOLDER FOR A LENGTH OF 6.2 CM. THE COILS WERE STILL INTACT. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. A DOC EXTENSION WIRE WAS RETURNED ATTACHED TO THE BMW GUIDE WIRE. THERE WAS NO DAMAGE NOTED TO THE DOC EXTENSION WIRE. ADDITIONALLY 55 PAC'S WERE RETURNED IN UNOPENED PACKAGES, THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRES. AN ATTEMPT WAS MADE TO ADVANCE THE DISTAL END OF THE GUIDE WIRE, INCLUDING THE HYPOTUBE, THROUGH A HOLE GAUGE, BUT DUE TO THE STRETCHED TIP COILS AND SEPARATED SHAPING RIBBON, THE GUIDE WIRE WOULD NOT ADVANCE. THIS DID NOT MEET MANUFACTURING CRITERIA. THE PROXIMAL END OF THE GUIDE WIRE, UP TO THE HYPOTUBE, PASSED THROUGH A HOLE GAUGE. THIS MET MANUFACTURING CRITERIA. AN ATTEMPT WAS MADE TO BACKLOAD THE GUIDE WIRE THROUGH A NEW BALLOON CATHETER, BUT DIE TO THE STRETCHED TIP COILS AND THE SEPARATED SHAPING RIBBON, THE GUIDE WIRE WOULD NOT ADVANCE. THE BMW GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED BMW GUIDE WIRE ANALYSIS OF THE RETURNED DEVICE WAS ABLE TO CONFIRM THE COMPLAINT AS THE SHAPING RIBBON WAS SEPARATED 2.1 CM DISTAL TO THE CENTER SOLDER, WITH THE TIP COILS STRETCHED DISTAL TO THE CENTER SOLDER FOR A LENGTH OF 6.2 CM. RESULTS OF THE SEM ANALYSIS INDICATE THAT THE DEVICE SHAPING RIBBON WAS SUBJECTED EXCESSIVE TORSIONAL OVERLOAD BEYOND ITS DESIGN LIMIT CAUSING THE SHAPING RIBBON TO SEPARATE. FOR THE GUIDE WIRE TO FAIL DUE TO TORSIONAL OVERLOAD, SOME PORTION OF THE GUIDE WIRE WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR IN ANOTHER DEVICE AND EXCESS TORQUE APPLIED. FROM THE INCIDENT DESCRIPTION, THE TIP OF THE GUIDE WIRE BECAME TRAPPED AND STUCK IN THE VESSEL. THE GUIDE WIRE MAY HAVE BEEN TORQUED AFTER IT WAS TRAPPED IN THE VESSEL AND FORCE WAS USED TO FREE THE GUIDE WIRE AS REPORTED IN THE CASE DESCRIPTION. IN THIS INSTANCE, THE DAMAGE APPEARS TO BE FROM CIRCUMSTANCES RELATED TO THE PROCEDURE AND NOT A MANUFACTURING RELATED QUALITY ISSUE. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT NUMBER AND PART NUMBER. THE REPORTED INCIDENT CIRCUMSTANCE WILL BE MONITORED. 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. IN ADDITION QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING AND VERIFY PRODUCT QUALITY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SHAPING RIBBON SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE SHAPING RIBBON SEPARATION. IT WAS REPORTED THAT THE BMW UNIVERSAL GUIDE WIRE WAS EASILY POSITIONED IN THE DISTAL PORTION OF THE VESSEL. AFTER STENTING THE LESION, AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE, BUT THE DISTAL PORTION STRETCHED FOR ABOUT 4 CM AND COULD NOT BE REMOVED. BY ADVANCING THE GUIDE CATHETER DEEPER AND USING FORCE, THE GUIDE WIRE WAS ABLE TO BE REMOVED. NO ADDITIONAL EVENT OR PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI- TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8031891

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR STENT: VISION| INFLATION: MDT| GUIDING CATHETER: MEDTRONIC JL4| SHEATH: CORDIS AVANTI PLUS