BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING?

    MDR report key: 3790451 · Received May 5, 2014

    Report

    Report Number
    2134265-2014-02389
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A STERLING BALLOON CATHETER WITH NO ORIGINAL PACKAGING. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. MAGNIFIED INSPECTION OF THE DEVICE REVEALED THAT THE SHAFT WAS NECKED, STRETCHED, AND BUCKLED 29.5CM FROM THE STRAIN RELIEF TO THE PROX WELD. THE PROXIMAL MARKERBAND WAS FOUND TO BE 4.5CM PROXIMAL OF THE PROXIMAL WELD. THE BALLOON WAS PROLAPSED OVER THE DISTAL TIP. THE EXTENSIVE DAMAGE NOTED ON THE CATHETER SUGGESTS TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WAS A BALLOON TEAR 28MM FROM THE DISTAL TIP CONSISTENT WITH THE REPORTED INFORMATION WHICH NOTES THAT THE PHYSICIAN PUNCTURED THE BALLOON. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE BALLOON WAS PUNCTURED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE STRETCHED AND NECKED AREAS OF THE SHAFT MAY HAVE CAUSED INFLATION LUMEN RESTRICTION WHICH IS A KNOWN FACTOR FOR INHIBITING BALLOON DEFLATION. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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).

    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 DEFLATION ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CUBITAL REGION. A 50/50 CONTRAST RATIO WAS USED. A 7.0MM X 40MM X 40CM STERLING¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS FIRST INFLATED FOR 30 SECONDS AT 14 ATMOSPHERES. THEN SECOND INFLATION WAS PERFORMED FOR 30 SECONDS AT 14 ATMOSPHERES. DEFLATION WAS ATTEMPTED BUT THE BALLOON ONLY DEFLATED AT APPROXIMATELY 10%-20%. DURING PREPARATION, IT WAS CONFIRMED THAT THE AIR WAS EVACUATED FROM THE DEVICE COMPLETELY. THERE WAS NO PROBLEM ENCOUNTERED WITH THE UNSPECIFIED INFLATION DEVICE. THE PHYSICIAN PUNCTURED THE BALLOON USING A PUNCTURE NEEDLE AND THE BALLOON WAS ABLE TO DEFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO PROBLEM AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CUBITAL REGION. A 50/50 CONTRAST RATIO WAS USED. A 7.0MM X 40MM X 40CM STERLING BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS FIRST INFLATED FOR 30 SECONDS AT 14 ATMOSPHERES. THEN SECOND INFLATION WAS PERFORMED FOR 30 SECONDS AT 14 ATMOSPHERES. DEFLATION WAS ATTEMPTED BUT THE BALLOON ONLY DEFLATED AT APPROXIMATELY 10%-20%. DURING PREPARATION, IT WAS CONFIRMED THAT THE AIR WAS EVACUATED FROM THE DEVICE COMPLETELY. THERE WAS NO PROBLEM ENCOUNTERED WITH THE UNSPECIFIED INFLATION DEVICE. THE PHYSICIAN PUNCTURED THE BALLOON USING A PUNCTURE NEEDLE AND THE BALLOON WAS ABLE TO DEFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO PROBLEM AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268598 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032704040 16464402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: KYOUSHA| INTRODUCER SHEATH: MOSQUITO SHEATH