ULTRATOME XL SPHINCTEROTOME

Description of Event or Problem

AN ULTRATOME XL SPHINCTEROTOME DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN A FEMALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, "THE CUT WIRE BROKE WHILE IT WAS BEING BOWED." A SECOND ULTRATOME XL SPHINCTEROTOME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

Additional Manufacturer Narrative

A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE DISTAL END OF THE CUTTING WIRE HAD SEPARATED FROM THE ANCHOR NOTCH (STAINLESS STEEL TUBING), WHICH IS ANCHORED INSIDE THE DISTAL PIERCE HOLE OF THE EXTRUSION (FIGURE 1). AFTER DISSECTING THE RETURNED DEVICE, VISUAL EXAMINATION OF THE ANCHOR NOTCH (FIGURE 2) AND THE END OF THE CUTTING WIRE, DESIGNED TO BE SOLDERED TO THE ANCHOR NOTCH, REVEALED THAT THE CUTTING WIRE HAD DETACHED, APPARENTLY DUE TO AN INADEQUATE SOLDER JOINT. THE MOST PROBABLE CAUSE FOR THE SOLDER JOINT FAILURE IS THE MFG PROCESS, WHERE THE CUTTING WIRE SHOULD HAVE BEEN PROPERLY SOLDERED TO THE ANCHOR NOTCH DURING ASSEMBLY OF THE TWO COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS REPORTED FOR THE SAME LOT. AND, A REVIEW OF THE MARCH 2008 15-MONTH ULTRATOME XL- SPHINCTEROTOME PRODUCT FAMILY TREND CHART, INCLUSIVE OF ALL FAILURE MODES; NO UNFAVORABLE TREND WAS NOTED.