BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3022599 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01953
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON WAS RECEIVED IN A DEFLATED STATE. THE OUTER SHAFT WAS NECKED DOWN ONTO THE INNER SHAFT IN MULTIPLE LOCATIONS. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER; DIFFICULTY WAS ENCOUNTERED DURING INFLATION. THE DEVICE MAINTAINED RBP WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. THE DEVICE DEFLATED WITHIN TIME SPECIFICATION. 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 ANGIOPLASTY TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING INFLATION OF THE 8.0X40MM STERLING BALLOON CATHETER, THE BALLOON WOULD ONLY PARTIALLY INFLATE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. HOWEVER, IT TOOK "A NUMBER OF MINUTES" TO DEFLATE THE BALLOON COMPLETELY. THE DEVICE WAS REMOVED INTACT, BUT APPEARED DISTORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING INFLATION OF THE 8.0X40MM STERLING BALLOON CATHETER, THE BALLOON WOULD ONLY PARTIALLY INFLATE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. HOWEVER, IT TOOK ¿A NUMBER OF MINUTES¿ TO DEFLATE THE BALLOON COMPLETELY. THE DEVICE WAS REMOVED INTACT, BUT APPEARED DISTORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126494 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032804080 15764634

    Patients

    Seq Age Sex Outcome Treatment
    1