BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 1863830 · Received October 11, 2010

    Report

    Report Number
    1016427-2010-00119
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: THE PRODUCT CATALOG AND LOT NUMBER WAS RECEIVED. THE COMPLAINT REPORT STATED THAT BEFORE USING THE PRESILLION STENT ON A PATIENT, IT STUCK ON THE GUIDEWIRE AND WAS IMPOSSIBLE TO MOVE FURTHER. "THE GUIDEWIRE WITH THE STENT ON IT WAS TAKEN AWAY." THIS OCCURRED OUTSIDE THE PATIENT; THERE WAS NO INJURY. ADDITIONAL INFORMATION NOTED THAT THE WIRE WAS A CORDIS ATW STEERABLE GUIDEWIRE AND ONE PRESILLION STENT HAD BEEN SUCCESSFULLY IMPLANTED USING THIS WIRE PRIOR TO THE FREEZE-UP WITH THE 2ND PRESILLION STENT. THE WIRE COULD NOT BE USED FURTHER BECAUSE IT WAS STUCK IN THE PRESILLION GUIDEWIRE LUMEN. THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. NO ANOMALIES WERE NOTED PRIOR TO USE OR DURING PREP. (B)(4) - ONE NON-STERILE ATW STEERABLE GUIDEWIRE WAS RETURNED COILED INSIDE A PLASTIC BAG; THE GUIDEWIRE WAS RECEIVED WITH THE PRESILLION STENT DELIVERY SYSTEM. BOTH PIECES PRESENTED SEVERAL DAMAGES. THE GUIDEWIRE PRESENTED KINKS AND BENDS IN VARIOUS LOCATIONS ALONG ITS LENGTH. THE COIL TIP PRESENTED A BEND 5MM FROM THE DISTAL END AND A STRETCHED SECTION 2.3CM TO 3CM FROM THE DISTAL END. THE KINKS AND DAMAGE ON THE COIL TIP WERE OBSERVED UNDER THE MICROSCOPE; THE CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE GUIDEWIRE WAS INTRODUCED THROUGH THE PRESILLION CATHETER; NO RESISTANCE WAS NOTED BUT IT COULD NOT PASS COMPLETELY THROUGH THE GUIDEWIRE LUMEN DUE TO THE SHAFT DAMAGE. WHEN THE ATW WAS INTRODUCED THROUGH ANOTHER LAB SAMPLE SDS, NO RESISTANCE/FRICTION WAS NOTED. NOTE: LAKE REGION LOT NUMBER 04782219 IS CORDIS LOT NUMBER F1108802. PER LAKE REGION REPORT (B)(4) - LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 04782219. THIS PACKAGING LOT CONTAINED 480 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL LIMITED ON NOVEMBER 28, 2008. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. KINKS, BENDS, AND A STRETCHED COIL WERE CONFIRMED ON THE GUIDEWIRE. IT IS NOT KNOWN IF THESE DAMAGES MAY HAVE CONTRIBUTED TO THE FRICTION WITH THE PRESILLION STENT OR IF THE WIRE WAS DAMAGED AS A RESULT OF THE FRICTION WITH THE SDS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT. IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORT STATED THAT BEFORE USING THE PRESILLION STENT ON A PATIENT, IT STUCK ON THE GUIDEWIRE AND WAS IMPOSSIBLE TO MOVE FURTHER. THE GUIDEWIRE WITH THE STENT ON IT WAS TAKEN AWAY. THIS OCCURRED OUTSIDE THE PATIENT; THERE WAS NO INJURY. ADDITIONAL INFORMATION NOTED THAT THE WIRE WAS A CORDIS ATW STEERABLE GUIDEWIRE AND ONE PRESILLION STENT HAD BEEN SUCCESSFULLY IMPLANTED USING THIS WIRE PRIOR TO THE FREEZE-UP WITH THE 2ND PRESILLION STENT. THE WIRE COULD NOT BE USED FURTHER BECAUSE IT WAS STUCK IN THE PRESILLION GUIDEWIRE LUMEN. THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. NO ANOMALIES WERE NOTED PRIOR TO USE OR DURING PREP. PI # 1-BXONKH - THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE ATW STEERABLE GUIDEWIRE WAS RETURNED COILED INSIDE A PLASTIC BAG; THE GUIDEWIRE WAS RECEIVED WITH THE PRESILLION STENT DELIVERY SYSTEM. BOTH PIECES PRESENTED SEVERAL DAMAGES. THE GUIDEWIRE PRESENTED KINKS AND BENDS IN VARIOUS LOCATIONS ALONG ITS LENGTH. THE COIL TIP PRESENTED A BEND 5MM FROM THE DISTAL END AND A STRETCHED SECTION 2.3CM TO 3CM FROM THE DISTAL END. THE KINKS AND DAMAGE ON THE COIL TIP WERE OBSERVED UNDER THE MICROSCOPE; THE CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE GUIDEWIRE WAS INTRODUCED THROUGH THE PRESILLION CATHETER; NO RESISTANCE WAS NOTED BUT IT COULD NOT PASS COMPLETELY THROUGH THE GUIDEWIRE LUMEN DUE TO THE SHAFT DAMAGE. WHEN THE ATW WAS INTRODUCED THROUGH ANOTHER LAB SAMPLE SDS, NO RESISTANCE/FRICTION WAS NOTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. KINKS, BENDS, AND A STRETCHED COIL WERE CONFIRMED ON THE GUIDEWIRE. IT IS NOT KNOWN IF THESE DAMAGES MAY HAVE CONTRIBUTED TO THE FRICTION WITH THE PRESILLION STENT OR IF THE WIRE WAS DAMAGED AS A RESULT OF THE FRICTION WITH THE SDS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT. IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN SUCCESSFULLY DEPLOYED ONE PRESILLION STENT TO THE LEFT CORONARY ARTERY TARGET LESION WITHOUT ANY REPORTED PRODUCT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO DELIVER ANOTHER PRESILLION 3.5 X 12 MM STENT TO THE TARGET LESION BUT THE DEVICE BECAME STUCK/IMPEDED ON THE CORDIS ATW GUIDEWIRE AND COULD NOT BE ADVANCED FURTHER. THE EVENT OCCURRED OUTSIDE OF THE PATIENT'S BODY. THE STENT DELIVERY SYSTEM (SDS) AND GUIDEWIRE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE GUIDEWIRE WAS NOT USED AGAIN DURING THE CASE. THERE WAS NO REPORTED ISSUE WITH THE GUIDEWIRE. THERE WAS NO REPORTED LOSS OF ACCESS TO THE TARGET LESION. THERE WAS NO TARGET LESION INFORMATION AVAILABLE. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY THOUGH NO PROCEDURAL DETAILS WERE AVAILABLE. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU AND NO PROBLEMS WERE NOTED DURING PREPARATION. NO ADDITIONAL INFORMATION IS AVAILABLE. ADDENDUM: PRODUCT ANALYSIS OF THE ATW GUIDEWIRE RECEIVED INDICATED THAT THE DISTAL PORTION WAS UNRAVELED/STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F1108802

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PRESILLION 3.5 X 12 STENT DELIVERY SYSTEM