OPEN-END URETERAL CATHETER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3 (DATE OF EVENT). INVESTIGATION/EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON CONFORMANCES FOR THE REPORTED LOT NUMBER. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS FOR THE REPORTED LOT NUMBER. A REVIEW OF MANUFACTURING PROCEDURES FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE WAS NOT RETURNED FOR THIS COMPLAINT SO A DEVICE FAILURE ANALYSIS COULD NOT BE CARRIED OUT. COOK HAS NO MORE PRODUCT IN STOCK FROM THE SAME LOT AVAILABLE TO REVIEW IN PLACE OF THE COMPLAINT DEVICE. AS THERE ARE NO RELATED NON CONFORMANCES ON THE LOT, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DEVICE HISTORY RECORD WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THERE IS ALSO NO EVIDENCE TO SUGGEST THE COMPLAINT DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

A USER FACILITY SUS REPORT#: MW5088794 WAS RECEIVED ON 26AUG2019.

Additional Manufacturer Narrative

PMA/510K #: PRE-AMENDMENT. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED, PRIOR TO A CYSTOSCOPY, DURING WHICH A CATHETER WOULD BE PLACED IN THE RIGHT URETER, AN OPEN-END URETERAL CATHETER WAS INSPECTED AND NO VISIBLE ISSUE WAS FOUND. ONCE THE PROCEDURE WAS COMPLETED AND THE CATHETER WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THE TIP OF THE CATHETER WAS NO LONGER INTACT. USING THE CYSTOSCOPE THAT WAS STILL IN USE, THE PHYSICIAN AND OTHER HEALTHCARE STAFF WERE ABLE TO SEE THE PORTION OF THE TIP THAT HAD REMAINED WITHIN THE RIGHT URETER OF THE PATIENT. THE PHYSICIAN THEN USED STERILE GRASPERS TO REMOVE THE REMAINING PIECE OF THE CATHETER FROM THE PATIENT. NO OTHER PIECES OF THE CATHETER WERE SEEN WITH THE CYSTOSCOPE AND ALL 70 CM OF THE CATHETER WERE ACCOUNTED FOR. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS INCIDENT.