BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE GUIDING SHEATH

    MDR report key: 5849653 · Received August 5, 2016

    Report

    Report Number
    1820334-2016-00819
    Event Type
    Injury
    Date Received
    August 5, 2016
    Report Date
    July 19, 2016
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: NAVIEN 070, STRYKER EXCELSIOR XT-27 AND COVIDIEN ECHELON-10 CATHETERS. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: NAVIEN 070, STRYKER EXCELSIOR XT-27 AND COVIDIEN ECHELON-10 CATHETERS. (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INDICATIONS FOR USE, WARNINGS AND PRECAUTIONS. PER THE IFU "WHEN PUNCTURING, SUTURING OR INCISING THE TISSUE NEAR THE INTRODUCER, USE CAUTION TO AVOID DAMAGING THE INTRODUCER. AVOID EXTENDED EXPOSURE TO LIGHT. IF USING AN INTRODUCER WITH AQ HYDROPHILIC COATING, ACTIVATE HYDROPHILIC COATING BY WETTING THE OUTER SURFACE OF THE DEVICE WITH HEPARINIZED SALINE. NOTE: FOR BEST RESULTS, MAINTAIN WETTED CONDITION OF DEVICE DURING PLACEMENT. UPON REMOVAL FROM PACKAGING, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THE LIMITED AVAILABLE INFORMATION, IT IS NOT CLEAR IF THE ROOT CAUSE OF THE EVENT IS ASSOCIATED WITH THE PATIENT'S CONDITION, THE MEDICAL PROCEDURE, OR AN EVENTUAL MALFUNCTION OF THE 6F SHUTTLE, NAVIEN 070, EXCELSIOR XT-27, OR ECHELON-10 DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    M. SHAPIRO, M.D., ET AL: FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS: CLINICAL, RADIOGRAPHIC, AND HISTOPATHOLOGIC FEATURES. AJNR AM J NEURORADIOL 36:2121-26 NOV 2015. THE ABOVE REFERENCED JOURNAL ARTICLE ALLEGED THAT A PATIENT, IDENTIFIED AS PATIENT # 5, UNDERWENT Y-STENT-ASSISTED COILING OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM WITH SINGLE GROIN ACCESS CONSISTING OF 6F SHUTTLE, NAVIEN 070, EXCELSIOR XT-27 (STRYKER), AND ECHELON-10 (COVIDIEN) CATHETERS. EMBOLIZATION WAS NOTABLE FOR INTRA PROCEDURAL OCCLUSION OF 2 SUPERIOR DIVISION FRONTAL BRANCHES, WITH NO IMMEDIATE CLINICAL SEQUELAE. TRANSIENT EPISODES OF RIGHT UPPER EXTREMITY PARESTHESIA AND SPASM DEVELOPED 2 WEEKS POST EMBOLIZATION. CONVENTIONAL ANGIOGRAPHY DEMONSTRATED RECANALIZATION OF THE AFOREMENTIONED FRONTAL BRANCHES. MR IMAGING AND MR SPECTROSCOPY SHOWED MULTIPLE ENHANCING LESIONS THROUGHOUT THE LEFT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, THE LARGEST INVOLVING AREAS SUB SERVED BY INITIALLY OCCLUDED BRANCHES. A COURSE OF ORAL CORTICOSTEROIDS WAS ADMINISTERED. MR IMAGING 3 MONTHS AFTER THE EVENT SHOWED DECREASED PERILESIONAL EDEMA AND REDUCED ENHANCEMENT.

    Description of Event or Problem · 1

    M. SHAPIRO, M.D., ET AL: FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS: CLINICAL, RADIOGRAPHIC, AND HISTOPATHOLOGIC FEATURES AJNR AM J NEURORADIOL 36:2121-26 NOV 2015. THE ABOVE REFERENCED JOURNAL ARTICLE ALLEGED THAT A PATIENT, IDENTIFIED AS PATIENT # 5, UNDERWENT Y-STENT-ASSISTED COILING OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM WITH SINGLE GROIN ACCESS CONSISTING OF 6F SHUTTLE, NAVIEN 070, EXCELSIOR XT-27 (STRYKER), AND ECHELON-10 (COVIDIEN) CATHETERS. EMBOLIZATION WAS NOTABLE FOR INTRA PROCEDURAL OCCLUSION OF 2 SUPERIOR DIVISION FRONTAL BRANCHES, WITH NO IMMEDIATE CLINICAL SEQUELAE. TRANSIENT EPISODES OF RIGHT UPPER EXTREMITY PARESTHESIA AND SPASM DEVELOPED 2 WEEKS POST EMBOLIZATION. CONVENTIONAL ANGIOGRAPHY DEMONSTRATED RECANALIZATION OF THE AFOREMENTIONED FRONTAL BRANCHES. MR IMAGING AND MR SPECTROSCOPY SHOWED MULTIPLE ENHANCING LESIONS THROUGHOUT THE LEFT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, THE LARGEST INVOLVING AREAS SUB SERVED BY INITIALLY OCCLUDED BRANCHES. A COURSE OF ORAL CORTICOSTEROIDS WAS ADMINISTERED. MR IMAGING 3 MONTHS AFTER THE EVENT SHOWED DECREASED PERILESIONAL EDEMA AND REDUCED ENHANCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501475 FLEXOR SHUTTLE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening