BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHINOBI SGW

    MDR report key: 1636572 · Received March 22, 2010

    Report

    Report Number
    1016427-2010-00030
    Event Type
    Injury
    Date Received
    March 22, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 24, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K953760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. NOTE: (B) (4) LOT NUMBER 01789189 IS CORDIS LOT NUMBER F0809833. PER (B) (4) REPORT (B) (4): (B) (4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01789189. THIS PACKAGING LOT CONTAINED 100 UNITS, WHICH WERE SHIPPED FROM (B) (4) ON SEPTEMBER 14, 2009. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B) (4) AND WAS DETERMINED TO BE ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    DURING A PROCEDURE, A PHYSICIAN ATTEMPTED TO CROSS A CHRONIC TOTALLY OCCLUDED ILIAC WITH SEVERAL WIRES. ONE OF THE SHINOBI SGW'S DID NOT CROSS THE TARGET LESION. THE OTHER SHINOBI SGW BECAME IMPINGED. IT WAS LATER DISCOVERED ON FLUOROSCOPY AND UPON INSPECTION THAT THE DISTAL TIP HAD BROKEN OFF (FRACTURED/SEPARATED) IN THE CTO ILIAC LESION AND WAS LEFT THERE. NO INTERVENTION WAS PERFORMED. THE PATIENT WILL BE FOLLOWED MEDICALLY. NO PATIENT INJURY REPORTED. ONE NON-STERILE SGW SHINOBI PLUS 300 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. KINKS WERE FOUND ON THE CORE WIRE AT 32CM, 97CM, 135CM, 149.5CM, 173.5CM, 257.3CM AND 266.3CM FROM THE PROXIMAL END. THE DISTAL TIP PRESENTED KINKS AT 0.9CM, 1.5CM AND 2.3CM FROM THE DISTAL END. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE DISTAL TIP WAS INSPECTED UNDER MICROSCOPE AND NO FRACTURE WAS FOUND. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01789189. THIS PACKAGING (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED DURING MICROSCOPIC ANALYSIS. THE ANALYSIS SUGGESTS THAT PROCEDURAL FACTORS COULD HAVE CAUSED THE KINK DAMAGES FOUND ON THE CORE WIRE AND DISTAL TIP. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACCESS/CROSS THE CHRONIC TOTALLY OCCLUDED ILIAC ARTERY WITH SEVERAL GUIDEWIRES. ONE OF THE SGW SHINOBI PLUS 300 CM GUIDEWIRES USED FAILED TO CROSS THE TARGET LESION. THE OTHER SGW SHINOBI PLUS 300 CM GUIDEWIRES BECAME IMPINGED IN THE LESION. IT WAS LATER DISCOVERED ON FLUOROSCOPY AND UPON INSPECTION OF THE PRODUCT THAT THE DISTAL TIP OF THE GUIDEWIRE HAD BROKEN OFF AND WAS LEFT IN THE PATIENT. THE FRACTURED DISTAL TIP IS STILL IMBEDDED IN THE LESION. THE PROCEDURE WAS TERMINATED AT THIS POINT. THERE WAS NO ATTEMPT MADE TO RETRIEVE THE FRACTURED TIP. THE PATIENT WILL BE FOLLOWED MEDICALLY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    THE FILTER ATTACHMENT WAS FILLED WITH PARTICLES OF PLASTIC FROM OLD FILTERS. THE FILTER COULD NO LONGER FIT INTO THE ATTACHMENT, AND THERE WAS NO CHANCE OF REPAIR. A BACKUP PUMP WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHINOBI SGW CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0809833

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L