BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 8824500 · Received July 24, 2019

    Report

    Report Number
    2024168-2019-10342
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 13, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648014338
    PMA / PMN Number
    K101011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. A VISUAL AND DIMENSIONAL INSPECTIONS WAS PERFORMED. THE REPORTED GUIDE WIRE SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULT TO REMOVE WAS UNABLE TO BE CONFIRMED OR REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY REVEALED NO OTHER SIMILAR INCIDENTS. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT DURING MULTIPLE ADVANCEMENTS AND RETRACTIONS THROUGH THE ANATOMY, THE GUIDE WIRE LIKELY BECAME DAMAGED. ADDITIONAL MANIPULATION OF THE WIRE THROUGH THE PREVIOUSLY IMPLANTED STENT STRUTS, LIKELY CAUSED THE GUIDE WIRE TO GET CAUGHT BETWEEN THE STENT STRUTS RESULTING IN THE WIRE SEPARATION IN THE STENT AND STRETCHED COILS AND CAUSING THE APPEARANCE OF THE WIRE NOT TO TRACK AS INTENDED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. PATIENT CODE 2687 WAS REMOVED.

    Additional Manufacturer Narrative · 0

    G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.NA

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR REMOVAL OF THE GUIDE WIRE. ATTEMPTS TO SNARE AND RETRIEVE THE WIRE FRAGMENT WERE UNSUCCESSFUL; THEREFORE, IT WAS TRAPPED AGAINST THE VESSEL WALL BY DEPLOYING A STENT IN THE LEFT MAIN. THE PATIENT DID HAVE REDUCED CORONARY FLOW WHILE ADDITIONAL STENTS WERE PLACED, CAUSING PAIN AND PULMONARY EDEMA. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REQUIRED A PERIOD IN INTENSIVE CARE FOR SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE HAD BEEN PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND AN UNSPECIFIED STENT WAS PLACED FROM THE LEFT MAIN (LM) INTO THE LAD ACROSS THE CIRCUMFLEX (CX) OSTIUM. THE BMW GUIDE WIRE WAS THEN WITHDRAWN TO THE LM AND THE CX WAS WIRED THROUGH THE STRUTS OF THE LM-LAD STENT. THE CX OSTIUM WAS WIRED EASILY BUT THE TIP OF THE BMW APPEARED TO NOT TRACK PAST THE MID CX SO IT WAS WITHDRAWN INTO THE LM AND THEN ADVANCED INTO THE CX. THE TIP OF THE BMW APPEARED TO CATCH IN THE MID CX AGAIN SO IT WAS DECIDED TO WITHDRAW THE WIRE AND REPLACE WITH AN UNSPECIFIED GUIDE WIRE. UPON REMOVAL, A RADIOPAQUE PORTION REMAINED AT THE LM OSTIUM, INDICATING THAT IT HAD SEPARATED AND THE TIP WAS TRACKING INTO THE CX OSTIUM. THERE WAS NO REPORTED TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616707 HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 9031571 08717648014338

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R