OPEN-END URETERAL CATHETER

Additional Manufacturer Narrative

INITIAL REPORTER OCCUPATION: OPERATIONS MANAGER. PMA/510K#: PREAMENDMENT. INVESTIGATION ¿ EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE VISUAL EXAMINATION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF SPECIFICATIONS AND QUALITY CONTROL DATA. THE CUSTOMER SUPPLIED TWO IMAGES OF THE DEVICE FROM DURING THE PROCEDURE WHILST THE DEVICE WAS INDWELLING. THE 2ND IMAGE IS A SIDE VIEW OF THE CATHETER TIP SHOWING PART OF THE CATHETER IS MISSING CONFIRMING THE CUSTOMERS COMPLAINTS. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. COOK COULD NOT COMPLETE A TRACKWISE SEARCH OF OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY CONCLUSION: THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CARRIED OUT DUE TO THE LOT NUMBER BEING UNKNOWN. THE CUSTOMER REPORTED THE COMPLAINT DEVICE WAS DISPOSED OF UNINTENTIONALLY SO A DEVICE FAILURE COULD NOT BE CARRIED OUT. THE CUSTOMER PROVIDED IMAGES FROM DURING THE PROCEDURE WHICH SHOWS PART OF THE CATHETER APPEARS TO BE MISSING CONFIRMING THE CUSTOMERS COMPLAINT THE RISK ANALYSIS WAS CONDUCTED AND CONCLUDED NO ADDITIONAL RISK REDUCTION WAS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED DURING A RIGHT PYELOPLASTY, CYSTOSCOPY WITH RETROGRADE PYELOGRAM USING A RIGID URETEROSCOPE AND AN OPEN-END URETERAL CATHETER, THE CATHETER BROKE INSIDE THE PATIENT. THE DEVICE FRAGMENT WAS REMOVED FROM THE PATIENT'S BODY WITH A GRASPER AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE.