BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX¿ PLUS

    MDR report key: 2920559 · Received January 17, 2013

    Report

    Report Number
    3005099803-2013-00097
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. ANALYSIS OF THE RETURNED PERCUFLEX PLUS URETERAL STENT REVEALED THAT THE SHAFT OF THE STENT WAS KINKED. MARKS WERE OBSERVED ON THE BODY OF THE STENT AND THE SUTURE HOLE WAS SLIGHTLY RIPPED. THE TEAR AT THE SUTURE HOLE IS CONSISTENT WITH DAMAGE CAUSED BY THE SUTURE WHEN IT IS PULLED. THE SUTURE WAS NOT PRESENT WITH THE DEVICE RETURN. BOTH THE RENAL AND BLADDER PIGTAILS WERE PROPERLY FORMED WITHIN SPECIFICATION AND DID NOT SHOW ANY ANOMALIES OR DEFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF DEFORMED MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUFLEX PLUS URETERAL STENT PLACEMENT PROCEDURE, THE RENAL END OF THE STENT WAS UNABLE TO CURL PROPERLY IN THE KIDNEY. REPORTEDLY, THE DEVICE WAS INSPECTED PRIOR TO USE, AND NO DEFECT WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PERCUFLEX PLUS URETERAL STENT PLACEMENT PROCEDURE, THE RENAL END OF THE STENT WAS UNABLE TO CURL PROPERLY IN THE KIDNEY. REPORTEDLY, THE DEVICE WAS INSPECTED PRIOR TO USE, AND NO DEFECT WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26319 PERCUFLEX¿ PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061752620 15500162

    Patients

    Seq Age Sex Outcome Treatment
    1