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Patient 1
OUR PRODUCT EVALUATION LABORATORY RECEIVED 2 IMAGES FOR REVIEW. IMAGE 1 SHOWED A SECTION OF GUIDEWIRE, GUIDEWIRE ADVANCER AND TUBING. BLOOD WAS VISIBLE ON THE TUBING. IMAGE 2 SHOWED THE GUIDEWIRE WAS BROKEN INTO HALVES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF A BROKEN GUIDEWIRE WAS CONFIRMED ON EVALUATION. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS IS WELL DESCRIBED IN THE LITERATURE. THE SUGGESTED INSERTION PROCEDURE SECTION OF THE IFU ADVISES: ?D. INSERT THE DESIRED TIP (STRAIGHT OR ?J?) OF A GUIDEWIRE INTO THE PLACED CATHETER OR, IF USED, THE THIN-WALL NEEDLE. GENTLE MANIPULATION MAY BE NEEDED TO INSERT THE GUIDEWIRE. THE GUIDEWIRE SHOULD NEVER BE FORCED. IF DIFFICULTY IS MET DURING INSERTION OF THE GUIDEWIRE, COMPLETELY WITHDRAW THE GUIDEWIRE AND REATTEMPT INSERTION. CAUTION: TO AVOID POSSIBLE SEVERING OF THE GUIDEWIRE, DO NOT WITHDRAW AGAINST THE NEEDLE BEVEL. THIS CAN RESULT IN THE NEED FOR AN ADDITIONAL PERCUTANEOUS INTERVENTION TO RETRIEVE THE GUIDEWIRE. CAUTION: DO NOT WITHDRAW A PTFE-COATED GUIDEWIRE THROUGH A METAL NEEDLE AS THIS MAY DAMAGE THE GUIDEWIRE COATING, POTENTIALLY RESULTING IN AN EMBOLISM.? IT IS UNKNOWN WHETHER USER OR PROCEDURAL FACTORS CONTRIBUTED TO THE STATED EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.