BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVABLE CORE, STRAIGHT TIP

    MDR report key: 1192128 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05115
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    June 26, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #3005099803-2008-05094. IT WAS REPORTED, DURING CLINICAL FOLLOW-UP, THAT DURING AN UNSPECIFIED PROCEDURE, A PERFORATION OCCURRED. THE INTENT OF THE PROCEDURE WAS TO "UNBLOCK A STRICTURE" TO ALLOW URINE TO PASS. A NUMBER OF DIFFERENT DEVICES WERE USED DURING THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO PLACE SEVERAL COUNCIL TIPS, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REQUESTED A "CATHETERS GUIDE WITH COUNCIL TIP (SCREW TIP)", HOWEVER, THE DEVICE THE PHYSICIAN REQUESTED WAS UNAVAILABLE. THE PHYSICIAN USED A 0.035 MOVABLE CORE, STRAIGHT TIP UROLOGICAL GUIDE WIRE. "AFTER USING A 0.35 GLIDEWIRE TO INSERT 16FR. COUNCIL TIP 2WAY CATHETER, PATIENT'S SCROTUM WAS SWOLLEN TO THE SIZE OF CANTALOUPE." IT IS SUSPECTED THAT ONE OF THE INSTRUMENTS NICKED THE PATIENT'S URETHRA, CAUSING THE SCROTUM TO FILL WITH URINE. IT IS UNKNOWN WHICH DEVICE MAY HAVE CAUSED THE PERFORATION. THE PT WAS DISCHARGED HOME THE SAME DAY. THE SWELLING WAS TREATED WITH AN ATHLETIC SUPPORTER. THE FLUID WAS EXPECTED TO RE-ABSORB AND THE SWELLING WOULD GO DOWN ON ITS OWN. THE PHYSICIAN INDICATED THAT "IT WILL TAKE A LONG TIME FOR THE SWELLING TO COME DOWN." NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOVABLE CORE, STRAIGHT TIP EZB BOSTON SCIENTIFIC M0066201030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other URETERAL CATHETER| 0.035 GLIDEWIRE| URETHROTOME STRAIGHT COLD KNIFE| URETEROSCOPE| FILIFORM SPIRAL TIP CATHETER| 2 FILIFORM STRAIGHT TIP CATHETERS