BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATERFLEX PTCA GUIDE WIRE

    MDR report key: 2024144 · Received March 18, 2011

    Report

    Report Number
    3003775027-2011-00011
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K062186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. AGAINST RESISTANCE, FAILURE TO FOLLOW STEPS/INSTRUCTIONS. GUIDE WIRE: CORDIS STABILIZER PLUS. STENT: PROMUS 2.5 X 28 MM. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4): FROM THE PROVIDED INFORMATION, IT IS CONCLUDED THAT THE STENT WAS DEPLOYED IN A CONDITION WHERE THE GUIDE WIRE IS ADVANCED IN PARALLEL WITH THE STENT SYSTEM, SO THAT THE TIP OF THE GUIDE WIRE WAS TRAPPED BY THE DEPLOYED STENT, PULL-BACK MANIPULATION APPLIED UNDER SUCH CONDITIONS RESULTED IN SEPARATION OF THE TRAPPED GUIDE WIRE DUE TO THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT. WARNING SECTION OF THE INSTRUCTIONS FOR USE DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED, RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. DO NOT PRACTICE STENT DELIVERY WHEN USING THIS GUIDE WIRE FOR PARALLEL WIRE TECHNIQUE. SEPARATION OR BREAKAGE OF GUIDE WIRE AS ONE OF THE POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. INVESTIGATION OF THE PRODUCTION RECORD COULD NOT BE CONDUCTED AS NO LOT INFORMATION WAS AVAILABLE. SHIPPED PRODUCTS ARE ALL INSPECTED FOR APPROPRIATENESS DURING PRODUCTION PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MID CIRCUMFLEX ARTERY, A 2.5X28 PROMUS STENT SYSTEM WAS ADVANCED ON A NON-ABBOTT GUIDE WIRE. SOME RESISTANCE WAS FELT; THEREFORE, A PROWATER FLEX GUIDE WIRE WAS INTRODUCED AS A BUDDY WIRE. THE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY OVER THE NON-ABBOTT GUIDE WIRE. AN ATTEMPT WAS MADE TO REMOVE THE PROWATER GUIDE WIRE, BUT THE DISTAL SEGMENT OF THE GUIDE WIRE WAS TRAPPED UNDER THE DEPLOYED STENT. AN UNSPECIFIED BALLOON WAS ADVANCED IN AN UNSUCCESSFUL ATTEMPT TO RELEASE THE GUIDE WIRE. THE BALLOON CATHETER WAS REMOVED FROM THE ANATOMY AND THE PHYSICIAN PULLED THE GUIDE WIRE USING MODERATE FORCE. THE GUIDE WIRE DETACHED. THE DISTAL TIP OF THE GUIDE WIRE REMAINED TRAPPED BY THE STENT WITH 5-10MM OF THE GUIDE WIRE TRAVERSING DOWN INTO THE AORTA. THE PROXIMAL SEGMENT OF THE GUIDE WIRE WAS WITHDRAWN AFTER DETACHMENT OF THE GUIDE WIRE. THE PATIENT DECLINED SURGERY AND NO INTERVENTION IS PLANNED. THE PROCEDURE WAS PROLONGED 30-40 MINUTES. PATIENT CONDITION IS REPORTED AS STABLE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATERFLEX PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4)