IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE. REPORTEDLY ON ATTEMPT TO PULL OUT THE BONE BIOPSY DEVICE, THE TAUPE-COLORED HANDLE "RIPPED OFF" THE ALUMINUM SHAFT. THE PHYSICIAN NOTED THAT THE PATIENT'S VERTEBRAL BODY WAS VERY SCLEROTIC AND THE ONE BIOPSY DEVICE BECAME STUCK IN THE BONE. PLIERS WERE THEN USED TO REMOVE THE DEVICE, CAUSING THE SHAFT TO PINCH CLOSED. AFTER REMOVING THE DEVICE FROM THE WORKING CANNULA, THE PINCHED TIP WAS CUT OFF IN AN ATTEMPT TO OBTAIN THE VERTEBRAL TISSUE SAMPLE BY USING THE BONE BIOPSY PLUNGER. THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT AND NO ADVERSE EVENT OCCURRED. NO ADD'L INFO WAS REPORTED.
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Patient 1
METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE. CONCLUSION: TWO MOST LIKELY FACTORS CONTRIBUTING TO BREAKAGE OF THE HANDLE ARE ENTRAPMENT OF BONE PARTICULATE BETWEEN THE ACCESS CANNULA AND BINDING OF THE NOZZLE TIP IN THE VERTEBRAL BODY, WHICH WAS CAUSED BY DEFORMATION OF THE NOZZLE TIP. THE TIP OF THE NOZZLE WAS PROBABLY DEFORMED IN THE PROCEDURE DURING THE 1ST PASS. SCLEROTIC CONDITION OF THE PT'S BONE HAS CERTAINLY EXACERBATED THE EFFECTS OF BONE ENTRAPMENT AND MARKEDLY CONTRIBUTED TO DEFORMATION OF THE NOZZLE TIP.