BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCOMPASS NITINOL TIPLESS STONE EXTRACTOR

    MDR report key: 1218127 · Received October 31, 2008

    Report

    Report Number
    1825146-2008-00034
    Event Type
    Injury
    Date Received
    October 31, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE COMPLETE AND USED STONE EXTRACTOR WAS REC'D NOTING THE HANDLE TO BE IN THE OPEN POSITION ALONG WITH SMALLER PACKAGING CONTAINING THE BASKET, BASKET WIRES AND DISTAL CANNULA COMPLETELY DETACHED FROM THE INNER COIL. UPON CLOSE EXAMINATION OF THE WIRES AT THE POINT OF SEPARATION, THE ENDS OF THE WIRES HAVE THE APPEARANCE OF BEING PULLED UNTIL SEPARATION OCCURRED DUE TO THE WIRES BEING ELONGATED. THE INNER COIL WAS NOTED TO EXTEND FROM THE TIP OF THE SHEATH NOTING THE COILS ALSO HAVING STRETCHED APPEARANCE, AS WELL AS A KINK WAS OBSERVED IN THE COIL NOTING THE COILS HAVE THE APPEARANCE OF BEING STRETCHED FOR APPROX 5 CM IN LENGTH. THE OUTER SHEATH LENGTH MEASURED WITHIN SPEC INDICATING IT HAD NOT BEEN STRETCHED. THE DISTRIBUTOR WAS CONTACTED FOR ADD'L INFO INDICATING THE PHYSICIAN WAS USING A STORZ K27.411 SCOPE TO INSERT THE STONE EXTRACTOR AS WELL AS INDICATED THE STONE WAS LOCATED IN THE UPPER SIDE OF THE URINARY DUCT, ABOUT 1 CM ABOVE THE ORIFICE. THE PHYSICIAN IS UNCLEAR WHAT THE STONE EXTRACTOR COULD HAVE 'CAUGHT' ON DURING REMOVAL. WHEN THE SCOPE AND STONE EXTRACTOR BASKET WERE REMOVED FROM THE PT, THE PHYSICIAN USED A STROZ FORCEP TO CRUSH THE STONE. ONCE THE STONE WAS CRUSHED, THE PHYSICIAN ATTEMPTED TO PLACE A URETERAL STENT, HOWEVER, THE STRAIGHT WIRE GUIDE WAS OBSERVED GOING OUT OF THE URETER NOTING A SMALL TEAR THAT DID NOT REQUIRE REPAIR. AT THIS TIME, THE PHYSICIAN PLACED A PIGTAIL NEPHRECTOMY CATHETER. DUE TO THE APPEARANCE OF THE WIRES AND COIL, EXCESSIVE FORCE HAS MOST LIKELY CAUSED THE BASKET PORTION TO SEPARATE FROM THE STONE EXTRACTOR. SHOULD ADD'L INFO BECOME AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    "DURING TUL, DR USED THIS EXTRACTOR TO CATCH A CALCULUS OF 5 MM OR 6 MM. WHEN HE TRIED TO WITHDRAW IT WITH A WG, A 6FR CATHETER AND A SCOPE (STORZ K27.411, ABOUT 60 CM), THE BASKET GOT LODGED ABOVE THE URETERIC ORIFICE AND HE WITHDREW THE SCOPE OVER THE EXTRACTOR AND HELD IT THERE. HE CAUGHT THE EXTRACTOR SHEATH END BELOW THE URETERAL ORIFICE AND TRIED TO WITHDRAW IT. HE DID NOT MEAN TO PULL FIRMLY, BUT THE BASKET SEPARATED FROM THE SHEATH AT THE BASKET END. HE GAVE UP RETRIEVE THE CALCULUS AND CRASHED IT WITH A FORCEPS. HE WITHDREW THE REMAINING BASKET WITH THE BASKET OPEN USING THE FORCEPS. SECONDLY, HE TRIED TO PLACE A DOUBLE-J STENT WITH X-RAY, BUT THE CONTRAST MEDIA AND THE STRAIGHT WG LOOK GOING OUT OF THE URETER. DR NOTICED HE DAMAGED THE URETERIC WALL. AN ANGLED TIP WG ALSO DOES NOT WORK. HE GAVE UP PLACING A STENT RETROGRADELY AND PLACED A PIGTAIL NEPHROSTOMY CATHETER BY PNS. FOR THE PIERCE, HE WAITS FOR IT TO RECOVER SPONTANEOUSLY. DR REQUIRES CREDIT AND WANTS TO KNOW HOW LONG THE WIRE HAS EXTENDED DURING WITHDRAWAL AND SOME PHOTOS OF THIS COMPLAINT FOR HIS INFO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCOMPASS NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK UROLOGICAL, INC. NA U1749272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other