BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE

    MDR report key: 7331793 · Received March 12, 2018

    Report

    Report Number
    1018233-2018-00769
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 29, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAD
    PMA / PMN Number
    K043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. RECEIVED ONLY STENT NOT IN ORIGINAL PACKAGING FOR EVALUATION. PER THE VISUAL INSPECTION, THERE WAS NO SUTURE ON THE RETURNED STENT. THERE WAS NO BREAK FOUND. THE SAMPLE WAS SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "[WARNINGS] 1. METHOD FOR USE (1)WHEN USING THE MULTI-LENGTH TYPE STENT, IT SHOULD BE AVOIDED IN THE FOLLOWING CASES. 1)IF YOU MEASURE THE LENGTH OF PATIENT¿S URETER AND CONFIRM THAT EXCESSIVE COIL PART WOULD BE APPEAR , CONSIDER USING OTHER STENT WHICH HAS DIFFERENT SHAPE OF TIP AND LENGTH. URETERAL STENTS WITH EXCESSIVE COIL PART SHAVE RISKS OF KNOT FORMATION AT THE TIP OF RENAL PELVIS SIDE DURING PLACEMENT OR REMOVAL. 2) IF ANY RESISTANCE IS FELT DURING REMOVAL, CONFIRM THE CAUSE OF THE RESISTANCE WITH FLUOROSCOPY AND TAKE REMEDIAL ACTION TO SOLVE THE PROBLEM. EXCESSIVE FORCE DURING REMOVAL MAY LEAD TO DAMAGE OF THE RENAL PELVIS AND/OR URETER. (2) URETEROARTERIAL FISTULA MAY BE FORMED BETWEEN THE URETER AND THE AORTA OR THE ILIAC ARTERY AND RESULT IN MASSIVE HEMORRHAGE AT THE REPLACEMENT OF THE URETERAL STENT IF A URETERAL STENT IS PLACED FOR A LONG TERM IN A PATIENT WHO HAS UNDERGONE THE INTRAPELVIC SURGERY OR IRRADIATION. THEREFORE, CAREFULLY MONITOR THE CONDITION OF THE PATIENT, AND IN THE EVENT OF ACKNOWLEDGING BLEEDING FROM THE URETHRA, PERFORM RETROGRADE PYELOGRAPHY OR ANGIOGRAPHY, AND PROVIDE APPROPRIATE CARE. [CONTRAINDICATIONS] 1. METHOD FOR USE (1)DO NOT REUSE. (2)DO NOT RESTERILIZE 2. APPLICABLE PATIENTS DO NOT USE FOR THE WOMAN WHO IS PREGNANT OR MAY BECOME PREGNANT. [TO AVOID RADIATION EXPOSURE ON PRE-BORN BABY FROM X-RAY.] 2.PRECAUTIONS FOR USE <STENT> (1)DO NOT FORCIBLY INSERT OR REMOVE THE STENT. IT MAY INJURE PATIENT OR/AND DAMAGE THIS PRODUCT. (2)AVOID IMPROPER HANDLING OF STENT SUCH AS BENDING, KINKING, TEARING, ETC. MISUSE COULD DAMAGE THE OVERALL INTEGRITY OF THE STENT. (3)AVOID CONTACT WITH SHARP EDGES AS THIS MAY CAUSE DAMAGE TO THE STENT. IF GRASPING DEVICE IS USED, THE STENT SHOULD BE REMOVED FROM URETER FIRST. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. (4)DETERMINE THE PROPER STENT LENGTH FOR THE PATIENT. SELECTION OF TOO SHORT A STENT MAY RESULT IN MIGRATION. (5)IN THE EVENT OF STENT MIGRATION, CYSTOSCOPY OR URETEROSCOPY SHOULD BE USED TO RETURN THE STENT TO THE ORIGINAL POSITION OR REMOVE FROM THE PATIENT BODY. (6)ANY SIGNS OF INFECTION IN THE LOCATION OF THE STENT PLACEMENT REQUIRE REMOVAL OF THE STENT. AFTER CHECKING THE CONDITION OF THE PATIENT, A NEW STENT SHOULD BE PLACED. (7)CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT TO ELIMINATE TEARING OR FRAGMENTATION." 1069: "L" 2645: 'NL" CORRECTIONS: CONCOMITANT MEDICAL PRODUCTS AND DEVICE EVALUATED BY MFR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE STENT WAS FOUND BROKEN; THE EXACT BREAK POINT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE STENT WAS FOUND BROKEN; THE EXACT BREAK POINT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176001 BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE URETERAL STENT FAD C.R. BARD, INC. (COVINGTON) -1018233 MYBVT931

    Patients

    Seq Age Sex Outcome Treatment
    1