BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH

    MDR report key: 1150009 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00717
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE WHEN THE RIBBON SEPARATION OCCURRED. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE GUIDE WIRE WAS RETURNED WITH THE SHAPING RIBBON SEPARATED, 2.2CM DISTAL TO THE CENTER SOLDER. THE SEPARATED SHAPING RIBBON WITH THE TIPBALL AND TIP COILS WERE NOT RETURNED. THE RETURNED PART OF THE SHAPING RIBBON WAS IN A CORKSCREW SHAPE. THERE WERE OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 5.5CM. THE INTERMEDIATE COILS WERE IN A CORKSCREW FOR A LENGTH OF 18CM. THERE WERE TWO BENDS IN THE CORE, 24CM AND 32CM DISTAL TO THE PROXIMAL END OF THE HYPOTUBE. THERE WAS NO SCRAPPED TEFLON COATING VISIBLE TO THE GUIDE WIRE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THIS PRODUCT WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE. ANALYSIS OF THE RETURNED DEVICE WAS ABLE TO CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS RETURNED WITH THE INTERMEDIATE COILS IN A CORKSCREW SHAPE FOR A LENGTH OF 18CM. THE CORKSCREW SHAPE OF THE RETURNED GUIDE WIRE IS TYPICAL OF WHEN THE GUIDE WIRE IS CAUGHT IN THE CATHETER AND THE CATHETER IS ROTATED. THIS WRAPS THE GUIDE WIRE AROUND THE CATHETER. THIS WOULD BIND THE GUIDE WIRE TO THE CATHETER, BUT THE FACTOR THAT CAUSED THE GUIDE WIRE TO NOT ROTATE FREELY IN THE CATHETER COULD NOT BE DETERMINED FROM THE ANALYSIS; HOWEVER, IT COULD BE RELATED TO THE KISSING BALLOON TECHNIQUE AND THE ATTEMPTS TO REMOVE THE GUIDE WIRE FROM UNDERNEATH THE STENT. ANALYSIS OF THE RETURNED DEVICE ALSO FOUND THAT THE SHAPING RIBBON SEPARATED 2.2CM FROM THE CENTER SOLDER. THE SEPARATED SHAPING RIBBON WITH THE TIPBALL AND TIP COILS, WERE NOT RETURNED. SEM RESULTS OF THE FAILURE SITE ATTRIBUTED THE SEPARATION OF THE RIBBON TO DUCTILE OVERLOAD AND OF THE COILS TO TENSILE OVERLOAD. FOR THE GUIDE WIRE TO FAIL DUE TO DUCTILE OVERLOAD OR TENSILE OVERLOAD, SOME PORTION OF THE GUIDE WIRE WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR ANOTHER DEVICE AND EXCESSIVE PULL FORCE APPLIED. IN THIS CASE, THE KISSING BALLOON TECHNIQUE WAS BEING USED, WHICH SUGGEST, AS REPORTED, THAT THE GUIDE WIRE MIGHT HAVE BEING TRAPPED UNDER THE STENTS STRUTS. PULLING AGAINST RESISTANCE TO REMOVE THE GUIDE WIRE MIGHT HAVE CAUSED THE COIL DAMAGE, BENDS ON THE CORE, AND THE SEPARATION OF THE DEVICE. HOWEVER, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SEPARATION OF THE SHAPING RIBBON WAS CONFIRMED TO HAVE OCCURRED AFTER THE PROCEDURE DURING PACKAGING OR SHIPPING BACK TO ABBOTT VASCULAR. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE, WITH NO SCRAPPED TEFLON COATING VISIBLE TO THE GUIDE WIRE. OVERALL, BASED ON THE ANALYSIS OF THE RETURNED DEVICE, THE ISSUE APPEARS TO BE RELATED TO THE CIRCUMSTANCES DURING THE PROCEDURE; HOWEVER, SINCE THE SEPARATION WAS CONFIRMED BY THE ACCOUNT AS OCCURRING DURING TRANSPORT, A DEFINITIVE ROOT CAUSE FOR THE DISCREPANCIES CANNOT BE DETERMINED. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING A "KISSING-BALLOON" PROCEDURE, THE GUIDE WIRE WAS PULLED BACK UNDERNEATH THE STENT, AND THE GUIDE WIRE BECAME TWISTED AND THE TIP WAS STRETCHED. THERE IS NO ADDITIONAL EVENT OR PATIENT INFORMATION. THIS IS BEING FILED BASED ON THE DEVICE ANALYSIS THAT REVEALED THE SHAPING RIBBON WAS SEPARATED DUE TO DUCTILE OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8020485

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR