BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3202792 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04560
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STERLING CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN OPENED STERLING PRODUCT POUCH AND SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS A 50MM BLACK PIECE OF FM (FOREIGN MATTER) (HAIR) BETWEEN THE CARRIER TUBE AND CARRIER TUBE CLIP. BECAUSE THE PACKAGING WAS OPENED (AS-RECEIVED), THE ORIGIN OF THE FM COULD NOT BE DETERMINED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN UNPACKING PRIOR TO A STENTING TREATMENT PROCEDURE, FOREIGN MATTER WAS NOTED INSIDE THE PACKAGE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL CAROTID TO COMMON CAROTID ARTERY. A 4.5MMX30MMX135CM (4F) STERLING¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. A FOREIGN OBJECT WHICH MIGHT BE A HAIR WAS FOUND IN THE HOLDER OF THE DEVICE INSIDE THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN UNPACKING PRIOR TO A STENTING TREATMENT PROCEDURE, FOREIGN MATTER WAS NOTED INSIDE THE PACKAGE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL CAROTID TO COMMON CAROTID ARTERY. A 4.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. A FOREIGN OBJECT WHICH MIGHT BE A HAIR WAS FOUND IN THE HOLDER OF THE DEVICE INSIDE THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN UNPACKING PRIOR TO A STENTING TREATMENT PROCEDURE, FOREIGN MATTER WAS NOTED INSIDE THE PACKAGE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL CAROTID TO COMMON CAROTID ARTERY. A 4.5MMX30MMX135CM (4F) STERLING¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. A FOREIGN OBJECT WHICH MIGHT BE A HAIR WAS FOUND IN THE HOLDER OF THE DEVICE INSIDE THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301083 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031453010 15956306

    Patients

    Seq Age Sex Outcome Treatment
    1