BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1456042 · Received May 29, 2009

    Report

    Report Number
    2024168-2009-00948
    Event Type
    Malfunction
    Date Received
    May 29, 2009
    Date of Event
    April 24, 2009
    Report Date
    April 24, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD ON THE CORE. THERE WAS NO CONTRAST VISIBLE. THERE WAS A BEND IN THE SHAPING RIBBON 3 MM PROXIMAL TO THE TIPBALL. THERE WERE NUMEROUS AREAS ALONG THE CORE THAT HAD SCRAPED OFF TEFLON, THE LENGTHS VARIED FROM 1 MM TO 10 CM IN LENGTH. THERE WAS A BEND IN THE PROXIMAL CORE 17 CM PROXIMAL TO THE END OF THE GUIDE WIRE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THERE WERE EIGHT UNOPENED POUCHES OF GUIDE WIRES RETURNED, ALL WITH PART NUMBER 1001780-HC AND THE LOT NUMBER WAS 9030382. ALL THE POUCHES WERE OPENED AND THE GUIDE WIRES WERE VISUALLY INSPECTED. THERE WAS NO SCRAPED TEFLON NOTED ON ANY OF THE EIGHT GUIDE WIRE CORES. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT ON ALL THE GUIDE WIRES. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED THE CASE DESCRIPTION AND THE ANALYSIS OF THE RETURNED PRODUCT. DAMAGE TO THE TEFLON COATING CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, MANUFACTURING, DEVICE HANDLING, INTERACTION WITH PATIENT ANATOMY/LESION, AND/OR INTERACTION WITH OTHER DEVICES. PRODUCT PERFORMANCE ENGINEERING FURTHER INVESTIGATED AND NOTED THAT THE LOCATION OF THE TEFLON DAMAGE BEGAN 3 CM PROXIMAL TO THE DISTAL START OF THE TEFLON COATING, AND CONTINUED ALONG THE CORE. THERE WAS GREATER TEFLON DAMAGE AT THE PROXIMAL PORTION OF THE WIRE COMPARED TO THE DISTAL PORTION. THE LENGTHS OF THE SCRAPES VARIED BUT WERE SHARP AND JAGGED IN NATURE, INDICATING THAT THE WIRE CAME INTO CONTACT WITH A SHARP OBJECT. ALTHOUGH THE SOURCE OF THIS SHARP OBJECT COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE LOCATION OF THE TEFLON DAMAGE, IT IS POSSIBLE THAT INTERACTION WITH DEVICES CAUSED THE DAMAGE. IT WAS REPORTED THAT THE DIFFICULTY OCCURRED DURING A PROCEDURE TO TREAT IN STENT RESTENOSIS. IT IS POSSIBLE THAT THE GUIDE WIRE CAME INTO CONTACT WITH THE EDGE OR INNER BRAID OF THE GUIDING CATHETER DURING TREATMENT, AND ANY ADDITIONAL MOVEMENT OF THE WIRE, AS IN RETRACTION OR INSERTION, COULD SCRAPE THE TEFLON DISTALLY AS SEEN IN THE ANALYSIS. IT IS POSSIBLE THE GUIDING CATHETER WAS DAMAGED, HOWEVER, THE GUIDING CATHETER WAS NOT RETURNED, WHICH MAY HAVE AIDED IN THE EVALUATION. THE DAMAGE AT THE PROXIMAL AREA WAS CONSISTENT WITH THE DAMAGE CAUSED BY A TORQUE DEVICE. THE PUSHING/PULLING/TORQUING MOTION OF A TORQUE DEVICE AROUND A GUIDE WIRE COULD CAUSE THE SEVERITY OF SCRAPING SEEN IN THE ANALYSIS. IT IS UNLIKELY, DUE TO THE LOCATION OF THE TEFLON ON THE GUIDE WIRE, THAT THE TEFLON PORTION EXITED THE TIP OF THE GUIDING CATHETER AND ENTERED THE PATIENT'S ANATOMY. EIGHT UNOPENED GUIDE WIRES FROM THE SAME LOT WERE RETURNED. VISUAL ANALYSIS DID NOT NOTE ANY TEFLON DAMAGE. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND INDICATES THAT THIS LOT MET ALL THE MANUFACTURING REQUIREMENTS. ADDITIONALLY, THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION. ALTHOUGH A DEFINITE CAUSE OF WHAT CAUSED THE TEFLON DAMAGE COULD NOT BE DEFINITIVELY DETERMINED, BASED ON THE ANALYSIS OF THE RETURNED DEVICES, AND SINCE NO DAMAGE TO THE GUIDE WIRE WAS REPORTED PRIOR TO USE, THE DAMAGE APPEARS TO BE CAUSED BY CASE CIRCUMSTANCES. ANALYSIS OF THE RETURNED DEVICE ALSO FOUND A BEND IN THE SHAPING RIBBON 3 MM PROXIMAL TO THE TIPBALL. THIS BEND APPEARS TO BE RELATED TO THE SHAPE A PHYSICIAN NORMALLY APPLIES TO A GUIDE WIRE PRIOR TO USE AND DOES NOT APPEAR TO HAVE CAUSED THE REPORTED DIFFICULTY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: SCRAPED TEFLON COULD POTENTIATE EMBOLI. DEVICE ISSUE: SCRAPED TEFLON. IT WAS REPORTED THAT DURING USE OF THE GUIDE WIRE TO TREAT IN-STENT RESTENOSIS OF AN UNKNOWN STENT, THE PHYSICIAN NOTICED SOMETHING FORMING AROUND THE GUIDE WIRE, AND WHEN THEY WITHDREW THE GUIDE WIRE, THEY NOTICED A GREEN COLOR ON THE GUIDE WIRE. IT APPEARED AS IF THE TEFLON COATING WAS MELTING OR PEELING ON THE GUIDE WIRE. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. 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 9030382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK