BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1396954 · Received May 21, 2009

    Report

    Report Number
    2024168-2009-00898
    Event Type
    Injury
    Date Received
    May 21, 2009
    Date of Event
    April 27, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND BMW GUIDE WIRE (PART#1001780S-HC/LOT# 7111581) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. EVALUATION SUMMARY: QUALITY ASSURANCE REVEALED THAT THE FIRST GUIDE WIRE WAS RETURNED WITH BLOOD VISIBLE ON THE CORE, INTERMEDIATE AND TIP COILS. THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THE TIP PROLAPSED, 8 MM PROXIMAL TO THE TIPBALL. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE TIP OF THE GUIDE WIRE WAS TUGGED ON THE CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. QUALITY ASSURANCE REVEALED THAT THE SECOND GUIDE WIRE WAS RETURNED WITH BLOOD VISIBLE ON THE CORE, INTERMEDIATE AND TIP COILS. THERE WAS NO CONTRAST VISIBLE. THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS A PIECE OF CORE STILL ATTACHED AT THE DISTAL END OF THE HYPOTUBE. THE PROXIMAL END OF THE SEPARATION WAS NOT RETURNED. THERE WAS A BEND IN THE TIP, 9 MM PROXIMAL TO THE TIPBALL. THE PROXIMAL END OF THE GUIDE WIRE WAS NOT RETURNED. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THE GUIDE WIRE WAS ALSO SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. THE FIRST GUIDE WIRE WAS RETURNED WITH BLOOD VISIBLE ON THE CORE AND COILS, CONSISTENT WITH USE INSIDE A PATIENT'S ANATOMY. ANALYSIS CONFIRMED THE SEPARATION OF THE CORE AT THE DISTAL END OF THE HYPOTUBE. THE DISTAL PORTION OF THE SEPARATION WAS RETURNED. THERE WAS BEND IN THE TIP PROXIMAL TO THE TIPBALL WHICH MAY BE RELATED TO THE SHAPE A PHYSICIAN NORMALLY APPLIES TO A GUIDE WIRE PRIOR TO USE, OR FROM DAMAGE DURING RETRIEVAL OF THE GUIDE WIRE, AND DOES NOT APPEAR TO CONTRIBUTE TO THE REPORTED SEPARATION. THE SECOND GUIDE WIRE WAS RETURNED WITH BLOOD VISIBLE ON THE CORE AND COILS, CONSISTENT WITH USE INSIDE A PATIENT'S ANATOMY. ANALYSIS CONFIRMED THE SEPARATION OF THE CORE AT THE DISTAL END OF THE HYPOTUBE. THE PROXIMAL PORTION OF THE SEPARATION WAS NOT RETURNED. THE TIP WAS PROLAPSED PROXIMAL TO THE TIPBALL WHICH MAY BE RELATED TO RETRIEVAL OF THE GUIDE WIRE, AND DOES NOT APPEAR TO CONTRIBUTE TO THE REPORTED SEPARATION. SEM ANALYSIS WAS PERFORMED AND SUGGESTED THAT BOTH GUIDE WIRES MAY HAVE BEEN SUBJECTED TO DUCTILE OVERLOAD WHICH CAUSED THE CORE TO FAIL AND DETACH. A GUIDE WIRE BEING OVER PULLED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. IT IS POSSIBLE THAT THE GUIDE WIRE BECAME TRAPPED AT A SHARP ANGLE, SUCH AS AROUND THE ILIAC, AND ADDITIONAL ATTEMPTS TO MOVE THE GUIDE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE SEPARATION. IT IS ALSO POSSIBLE THAT THE GUIDE WIRES WERE UP AGAINST THE EDGE OF GUIDING CATHETER, AS BOTH SEPARATIONS WERE AT THE SAME LOCATION DISTAL TO THE HYPOTUBE. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED, WHICH MAY HAVE AIDED IN EVALUATION. THE ADDITIONAL THERAPY REPORTED APPEARS TO BE RELATED TO THE REMOVAL OF THE SEPARATED TIPS. TO ENSURE DAMAGE TO THE GUIDE WIRE DOES NOT OCCUR, A TIP PULL TEST IS ALSO PERFORMED ON EACH GUIDE WIRE TO ENSURE THE TIP IS PROPERLY ATTACHED. 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. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND INDICATES THAT THIS LOT MET ALL THE MANUFACTURING REQUIREMENTS. OVERALL, BASED ON THE CASE DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICES, AND SINCE NO DAMAGE WAS NOTED PRIOR TO USE, IT APPEARS THAT THE REPORTED SEPARATIONS ARE DUE TO CASE CIRCUMSTANCES. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: REMOVAL OF SEPARATED GUIDE WIRE FROM PATIENT. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON AN ILIAC LESION. A BMW 190 CM GUIDE WIRE BROKE INTO TWO PIECES, THE BREAKAGE WAS AT AROUND 40 CM FROM THE TIP. A BALLOON WAS INFLATED TO ENTRAP THE GUIDE WIRE, THEN IT WAS PULLED OUT. A NEW BMW GUIDE WIRE WAS USED IN ANOTHER ATTEMPT TO CROSS PASS THROUGH THE GUIDING CATHETER; HOWEVER, AGAIN IT BROKE IN THE SAME MANNER AND WAS PULLED OUT IN THE SAME MANNER. A PILOT 150 GUIDE WIRE WAS THEN USED AND WAS ABLE TO REACH LESION. THE PROCEDURE CONTINUED AND THE PATIENT WAS SUCCESSFULLY TREATED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7111581

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BMW GUIDE WIRE (PART#1001780S-HC/LOT# 7111581)