BANDER URETERAL DIVERSION STENT SET

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 DURING AN ATTEMPT TO REMOVE BANDER URETERAL DIVERSION STENT SET AFTER INDWELLING APPROXIMATELY 61 DAYS, THE USER HAD DIFFICULTY REMOVING THE STENT FROM THE PATIENT. IT WAS FOUND THAT THE STENT HAD TIED IN A KNOT. 2 DAYS LATER, THE PATIENT DEVELOPED A FEVER AND WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH ANTI-INFECTIVES. THIS REPORTEDLY ¿DID NOT TURN OUT WELL¿ (CLARIFICATION HAS BEEN REQUESTED). THE NEXT DAY, A RENAL NEPHROSTOMY WAS PERFORMED TO ALLOW URINE DRAINAGE. ONE WEEK LATER, THE STENT WAS REMOVED (NO DETAILS PROVIDED ON HOW THE STENT WAS EVENTUALLY REMOVED). (B)(6) 2019 IT WAS REPORTED THAT THE PATIENT IS NOW WELL WITH NO FEVER OR STOMACHACHE. EXACT DATE OF SYMPTOM RESOLUTION IS UNKNOWN. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. H6: EC RESULTS CODE DESC - 1: KNOTTED, INCORRECT. ADDITIONAL INFORMATION: D10. INVESTIGATION ¿ EVALUATION. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. VISUAL INSPECTION CONFIRMED THAT ONLY THE STENT CATHETER WAS RETURNED IN USED CONDITION. THE WIDTH OF THE COIL MEASURED 15MM. THE CATHETER MEASURED 33CM FROM THE COIL TO THE PROXIMAL END INDICATING APPROXIMATELY 37CM OF THE CATHETER WAS NOT RETURNED. THE CATHETER WAS TIED INTO A KNOT 10CM FROM THE COIL. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THE SET LOT RECORD HAD NO NON CONFORMANCES RECORDED. THE STENT COMPONENT LOTS RECORDS HAD 34 NON CONFORMANCES RECORDED. AS ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DEVICE HISTORY RECORD WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. AS PER CLINICAL ASSESSMENT, THERE WAS NO REPORTED INFORMATION REGARDING ANY CHALLENGES ENCOUNTERED WITH THE PATIENT¿S ANATOMY OR DEVICE PLACEMENT. HOWEVER, THERE WAS RADIOLOGIC IMAGING THAT SHOWED A DENSITY OF SOME SORT THAT COULD BE A LARGE STONE OR TUMOR THAT COULD HAVE HINDERED ITS PLACEMENT. THERE WAS NO INFORMATION IF ANY TECHNIQUES WERE USED TO ATTEMPT STRAIGHTENING OF THE DEVICE PRIOR TO REMOVAL. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY AND ANALYSIS OF THE RETURNED DEVICE. THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED BASED ON THE RETURNED DEVICE. A REVIEW OF THE COMPLAINT DATABASES DID NOT FIND ANY ADDITIONAL COMPLAINTS REPORTED FOR THE LOT AT THE TIME OF THIS INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NON CONFORMANCES FOR THE CURL DIAMETER BEING INCORRECT. THE NON CONFORMING PRODUCT WAS DOCUMENTED AS BEING SCRAPPED. A CLINICAL REVIEW COULD NOT IDENTIFY THE CAUSE OF THE COMPLAINT. CAUSE OF EVENT IS UNKNOWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE LAST REPORT WAS SUBMITTED ON 13SEP2019.