BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3950102 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04171
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: RETURNED DEVICE CONSISTED OF A STERLING BALLOON CATHETER WITH A STOPCOCK ATTACHED TO THE HUB. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. INSPECTION UNDER MAGNIFICATION REVEALED THE BALLOON MATERIAL WAS TORN 26MM IN LENGTH. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES ON THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. NO PROXIMAL WELD DAMAGE WAS FOUND. OTHER THAN THE IDENTIFIED DAMAGE, THERE WERE 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

    SAME CASE AS: MDR ID # 2134265-2014-04169. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, PREDILATION WAS PERFORMED WITH A 5MM X 40MM STERLING¿ BALLOON CATHETER AND A 10MM X 40MM NON BSC STENT WAS DEPLOYED. THE 8.0MMX40MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION. THE DEVICE WAS EXCHANGED TO AN 8.0MMX40MMX80CM STERLING¿ BALLOON CATHETER. THE BALLOON WAS INFLATED BUT IT RUPTURED AT 8 ATMOSPHERES ON THE FIRST INFLATION. NO SEGMENT OF THE TWO BALLOONS WERE DETACHED AFTER THEY RUPTURED. THE PROCEDURE WAS COMPLETED WITH AN 8MM X 20MM STERLING¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID # 2134265-2014-04169. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, PREDILATION WAS PERFORMED WITH A 5MM X 40MM STERLING BALLOON CATHETER AND A 10MM X 40MM NON BSC STENT WAS DEPLOYED. THE 8.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR POST DILATION. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION. THE DEVICE WAS EXCHANGED TO AN 8.0MMX40MMX80CM STERLING BALLOON CATHETER. THE BALLOON WAS INFLATED BUT IT RUPTURED AT 8 ATMOSPHERES ON THE FIRST INFLATION. NO SEGMENT OF THE TWO BALLOONS WERE DETACHED AFTER THEY RUPTURED. THE PROCEDURE WAS COMPLETED WITH AN 8MM X 20MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428931 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032804080 16178622

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE:TREASURE FLOPPY| BALLOON CATHETER: 5MMX40MM STERLING| STENT: 10MMX40MM ABSOLUTE