BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2003928 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01267
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 CUSTOMER IS RETAINING THE DEVICE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE TIP SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL OVERLOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE GUIDE WIRE AS DESCRIBED. THERE WAS NO DEFINITE INDICATION IN THE CASE DESCRIPTION AS TO WHAT MAY HAVE CAUSED THE GUIDE WIRE TO BECOME TRAPPED; HOWEVER, PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. NO DAMAGE TO THE GUIDE WIRE TIP WAS REPORTED PRIOR TO USE, WHICH COULD INDICATE THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. REPORTEDLY, THE SEPARATED PORTION WAS RETRIEVED WITH A SNARE DEVICE. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED GUIDE WIRE TIP SEPARATION AND THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT OF RETRIEVING THE SEPARATED PORTION WITH A SNARE DEVICE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE WILL MONITOR THE INCIDENT CIRCUMSTANCES. MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS ALSO NOTED TWO KINKS IN THE CORE, 110 CM AND 154 CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE WHICH IS CONSISTENT WITH PRODUCT HANDLING DURING THE PROCEDURE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THE SEPARATED PORTION WAS RETURNED. THERE WAS A SMALL PIECE OF THE CORE REMAINING IN THE HYPOTUBE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE FAILURE OF THE CORE MAY BE ATTRIBUTED TO DIMPLE RUPTURE, INDICATING DUCTILE OVERLOAD AT A BEND. IT WAS NOTED THAT THERE WAS CORE EXTENDING OUT THE HYPOTUBE, INDICATING THE HYPOTUBE WAS PROPERLY ATTACHED TO THE CORE. FOR THE GUIDE 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 FORCES TO CAUSE A SEPARATION. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN PRODUCTS CAN ALL BE FACTORS. BASED ON THE RETURNED PRODUCT ANALYSIS AND THE SCANNING ELECTRON MICROSCOPE 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. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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 PATIENT WAS FOUND TO HAVE AN OCCLUDED LEFT INTERNAL JUGULAR AND LEFT AXILLARY VEINS EXTENDING TO THE CENTRAL VEINS, OCCLUDED LEFT SUBCLAVIAN AND INNOMINATE VEINS, AND A STENOTIC SUPERIOR VENA CAVA (SVC). A NON-ABBOTT BALLOON WAS USED TO ANGIOPLASTY THE SVC, THE INNOMINATE, THE RIGHT SUBCLAVIAN AND THE AXILLARY VEINS. THERE WAS GOOD FLOW FROM THE ARM UNTIL THE SUBCLAVIAN, WHERE THERE WAS A TIGHT STENOSIS. THE NON-ABBOTT GUIDE WIRE WAS EXCHANGED FOR THE BALANCE HEAVYWEIGHT (BHW) GUIDE WIRE AND A NON-ABBOTT BALLOON TO ANGIOPLASTY THE SUBCLAVIAN LESION, AT WHICH TIME A DISSECTION OCCURRED. ANOTHER NON-ABBOTT BALLOON WAS USED TO TREAT THE DISSECTION WITH LONG INFLATIONS. WHEN THE BALLOON WAS REMOVED, IT WAS NOTED THAT THE BHW GUIDE WIRE HAD COME APART AT A JUNCTION POINT AND THAT THE GUIDE WIRE WAS STILL IN PLACE IN THE DISTAL SEGMENT IN THE HEART AND THE PROXIMAL SEGMENT WAS IN THE AXILLARY VEIN. USING A COMBINATION OF INTRAVASCULAR SNARE AND BALLOON, THE BHW GUIDE WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE THROUGH-OUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED IN A VASCULAR PROCEDURE IN THE LEG. THE TIP OF THE GUIDE WIRE SEPARATED IN THE AREA AT THE TRANSITION OF THE SOLDER. THE SEPARATED PORTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 0110281

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention DILATATION CATHETER: SAVVY 4MM