A HYDRA JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, ON A FEMALE PATIENT (PATIENT AGE, AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, WHILE ACCESSING THE AMPULLA AND BILE DUCT AT THE SITE OF THE WIRE WHERE THE 10CM HYDROPHILIC DREAM TIP MEETS THE SHAFT OF THE JAGWIRE BODY, THE BLACK HYDROPHILIC TIP BECAME SEPARATED FROM THE BODY OF THE WIRE. THIS RESULTED IN A RIDGE THAT MADE CANNULATION CHALLENGING, AND ALSO MADE THE "UNDER WIRE" (THE NON COATED PART OF THE WIRE) VISIBLE. THE PHYSICIAN NOTICED THIS AND REMOVED THE WIRE FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRA JAGWIRE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
N
Patient 1
REMOVAL OF FOREIGN BODY. NO IMPACT OR CONSEQUENCES TO THE PATIENT. COMPONENT, DETACHMENT OF. A VISUAL EVALUATION PERFORMED ON THE RETURNED DEVICE REVEALED, THAT THE POLY TIP SEPARATED FROM THE FLARE EXPOSING APPROXIMATELY 8 MM OF THE CORE WIRE. THE ENTIRE POLY TIP IS PRESENT AND IN TACT. THE POLYURETHANE TIP IS STILL ADHERED TO THE CORE WIRE AND THERE IS EVIDENCE SHOWING THAT THE POLY FLOWED (MIGRATED) INTO THE TEFLON SLIP (FLARE). DAMAGE TO THE PTFE JACKET FLARE AND PROXIMAL POLY END WAS NOTED. THERE IS ALSO DAMAGE NOTED TO THE PTFE JACKET. THE DAMAGE IS LOCATED APPROXIMATELY 7.5 CM- 8 CM MEASURING FROM THE FLARE. THE POLY TIP WAS CUT IN ORDER TO DETERMINE IF THE POLYURETHANE TIP HAS MOVED. THE CORE WIRE IS WITHIN THE POLY WITH ONLY APPROXIMATELY 1 MM OF POLY EXTENDING OVER THE CORE WIRE ITSELF. THE DAMAGE NOTED TO THE PTFE JACKET MAY HAVE OCCURRED DURING RETRIEVAL OF THE TORQUING DEVICE. THUS CAUSING THE DAMAGE NOTED TO THE POLY PROXIMAL END AND FLARE. THIS IS BASED ON THE EVIDENCE PRESENTED BY THE WIRE. THE CUSTOMER DID NOT INDICATED THAT THE CONDITION WAS NOTED PRIOR TO USE. THE MOST PROBABLE CAUSE OF THE FAILURE MAY BE DUE TO THE WIRE COMING IN CONTACT WITH AN OBJECT OR INSTRUMENT UPON RETRIEVAL OF THE WIRE.