BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1813347 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03701
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A BLOOD-LIKE SUBSTANCE WAS VISIBLE IN THE INNER SHAFT AND BALLOON. THE OUTER SHAFT WAS SEPARATED APPROXIMATELY 39.5 CM FROM THE HUB. THE INNER SHAFT WAS SEPARATED AT THE BOND THAT JOINS THE INNER-OUTER SHAFT COMPONENTS PROXIMAL OF THE BALLOON. THE DISTAL INNER SHAFT WAS ALSO SEPARATED APPROXIMATELY 2.2 CM FROM THE DISTAL TIP. THE PORTION OF THE INNER SHAFT BETWEEN THE TWO SEPARATIONS WAS NOT RETURNED WITH THE DEVICE. THE MARKERBANDS WERE DETACHED FROM THE INNER SHAFT AND INSIDE THE BALLOON. THE DISTAL TIP WAS DAMAGED , INCLUDING SCRATCHES THAT MAYBE CONSISTENT WITH INTERACTION WITH A HEAVILY STENOSED AND/OR CALCIFIED LESION. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED THAT THE DISTAL END OF THE BALLOON WAS BUNCHED-UP. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE THE TIP OF THE BALLOON CATHETER FRACTURED. THE LESION BEING TREATED WAS LOCATED IN A DIALYSIS SHUNT. THE LESION SITE WAS SEVERELY STENOSED. THE BALLOON WAS INFLATED WITH A MANOMETER TO 8 TO 10ATM. DURING INFLATION THE TIP OF THE CATHETER SEPARATED FROM THE CATHETER SHAFT INSIDE THE PATIENT. A SMALL PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL. DUE TO THIS EVENT, THE DIALYSIS SHUNT COMPLETELY CLOSED. FOLLOWING SURGERY, THE PATIENT'S STATUS WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE THE TIP OF THE BALLOON CATHETER FRACTURED. THE LESION BEING TREATED WAS LOCATED IN A DIALYSIS SHUNT. THE LESION SITE WAS SEVERELY STENOSED. THE BALLOON WAS INFLATED WITH A MANOMETER TO 8 TO 10ATM. DURING INFLATION THE TIP OF THE CATHETER SEPARATED FROM THE CATHETER SHAFT INSIDE THE PATIENT. A SMALL PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL. DUE TO THIS EVENT, THE DIALYSIS SHUNT COMPLETELY CLOSED. FOLLOWING SURGERY, THE PATIENT'S STATUS WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032704040 13370194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention