BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3933924 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04027
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER RECEIVED INSIDE THE OPENED PRODUCT POUCH. THE BATCH NUMBER ON THE RETURNED PACKAGING AND DEVICE MATCHED THE REPORTED BATCH NUMBER. THE SEAL OF THE PRODUCT POUCH WAS OPENED ON THE LEFT SIDE WHERE THE TYVEK AND POLY MATERIAL MEET. THE AREA OF SEPARATION FROM TYVEK AND POLY SHOWS A RESIDUAL OF (B)(6) MATERIAL WHICH INDICATES A SEAL WAS PRESENT BETWEEN THE TYVEK AND THE POLY MATERIAL. UNIFORM WITNESS MARKS ON THE SIDE SEAL GIVE NO VISUAL OR TACTILE INDICATION OF A POSSIBLE SEAL DEFECT. THE PRODUCT POUCH WAS OPEN, AS-RECEIVED IN THE CIS LAB; HOWEVER, THERE WAS NO EVIDENCE OF A DEFECTIVE SEAL AND NO INDICATION THAT THE POUCH WAS OPENED PRIOR TO SHIPMENT FROM BSC. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEEL POUCH WAS COMPROMISED. A 20MM X 4.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING UNPACKING, IT WAS NOTED THAT THE PEEL POUCH PACKAGING WAS ALREADY OPENED. THE PRODUCT INSIDE THE PEEL POUCH WAS COMPROMISED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEEL POUCH WAS COMPROMISED. A 20MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING UNPACKING, IT WAS NOTED THAT THE PEEL POUCH PACKAGING WAS ALREADY OPENED. THE PRODUCT INSIDE THE PEEL POUCH WAS COMPROMISED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412842 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912520400 15479264

    Patients

    Seq Age Sex Outcome Treatment
    1