BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHOLEY HI-TORQUE GUIDE WIRE

    MDR report key: 2173565 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05099
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K083706
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE INFLUENCED BY PHYSICIAN TECHNIQUE, PATIENT ANATOMICAL MORPHOLOGY, AND PATIENT DISEASE STATE. HAVING THE APPROPRIATE EQUIPMENT SELECTED FOR USE, RELATED TO THE CASE CONDITIONS, CAN ALSO SIGNIFICANTLY AFFECT CROSSING AND IT IS EXPECTED THAT WIRES WITH DIFFERENT PERFORMANCE PROPERTIES WOULD PERFORM DIFFERENTLY IN CROSSING ATTEMPTS. THE WIRE CAN ALSO BE DAMAGED IN THE ATTEMPT TO CROSS. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. REPORTEDLY, THE GUIDE WIRE WOULD NOT ADVANCE AND CAUSED A PERFORATION AND IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE WARNINGS SECTION: OBSERVE ALL GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED UNDER FLUOROSCOPY. DO NOT TORQUE A GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, VESSEL TRAUMA MAY OCCUR. IN ORDER TO ENSURE THAT FAILURE TO CROSS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS 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. 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 THIS LOT. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INABILITY TO ADVANCE, BUT THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PERFORATION, AS LISTED IN THE WHOLEY INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHOLEY GUIDE WIRE CAUSED A PERFORATION DURING THE PROCEDURE. A JOSTENT GRAFTMASTER STENT WAS THEREFORE PLACED AT THE LESION SITE TO COVER THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A HEART CATHETERIZATION PROCEDURE, THE WHOLEY GUIDE WIRE WOULD NOT ADVANCE AND CAUSED A PERFORATION AT THE ATERIOVENOUS MALFORMATION. A JOSTENT GRAFTMASTER WAS USED TO TREAT THE PERFORATION SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHOLEY HI-TORQUE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1030803

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention GUIDE WIRE: BALANCE MIDDLEWEIGHTSHEATH: 5 FR