SOF-FLEX MULTI-LENGTH URETERAL STENT SET

Description of Event or Problem

ON (B)(6) 2017, THE URETERAL STENT FROM A SOF-FLEX MULTI-LENGTH URETERAL STENT SET WAS PLACED CYSTOSCOPICALLY WITH FLUOROSCOPIC GUIDANCE TO TREAT CHRONIC OBSTRUCTION AT THE TRANSPLANT URETEROVESICAL JUNCTION. NO OTHER COOK DEVICES WERE USED. ON (B)(6) 2017 (38 DAYS POST-PROCEDURE), THE STENT WAS REMOVED CYSTOSCOPICALLY USING ULTRASOUND AND CT DUE TO A FUNGAL URINARY TRACT INFECTION (UTI) WITH A FEVER. THE DEVICE FUNCTIONED AS INTENDED WITH NO MALFUNCTIONS REPORTED. THE STENT WAS REPLACED ON (B)(6) 2017 AND FINALLY REMOVED ON (B)(6) 2017, WITH NO FURTHER COMPLICATIONS. THE SITE REPORTED THE FUNGAL UTI WAS CONSIDERED RELATED TO THE STENT PLACEMENT, BUT NOT TO ANY ANCILLARY DEVICE, STUDY PROCEDURE, OR DEVICE DEFICIENCY. THE DEVICE WAS CORRECTLY POSITIONED, PROVIDED ADEQUATE DRAINAGE, AND DID NOT MALFUNCTION.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. H3: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

CORRECTION: D6A, D6B, D8, G2 (STUDY REFERENCE #: (BM)(6)), H3 (DEVICE NOT RETURNED), H6 (ANNEX E AND G CODES). INVESTIGATION ¿ EVALUATION: ON (B)(6) 2017, THE URETERAL STENT FROM A SOF-FLEX MULTI-LENGTH URETERAL STENT SET WAS PLACED CYSTOSCOPICALLY WITH FLUOROSCOPIC GUIDANCE TO TREAT CHRONIC OBSTRUCTION AT THE TRANSPLANT URETEROVESICAL JUNCTION. NO OTHER COOK DEVICES WERE USED. ON (B)(6) 2017 (38 DAYS POST-PROCEDURE), THE STENT WAS REMOVED CYSTOSCOPICALLY USING ULTRASOUND AND CT DUE TO A FUNGAL URINARY TRACT INFECTION (UTI) WITH A FEVER. THE DEVICE FUNCTIONED AS INTENDED WITH NO MALFUNCTIONS REPORTED. THE STENT WAS REPLACED ON (B)(6) 2017 AND FINALLY REMOVED ON (B)(6) 2017, WITH NO FURTHER COMPLICATIONS. THE SITE REPORTED THE FUNGAL UTI WAS CONSIDERED RELATED TO THE STENT PLACEMENT, BUT NOT TO ANY ANCILLARY DEVICE, STUDY PROCEDURE, OR DEVICE DEFICIENCY. THE DEVICE WAS CORRECTLY POSITIONED, PROVIDED ADEQUATE DRAINAGE, AND DID NOT MALFUNCTION. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY ANY POTENTIAL DISCREPANCIES PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON THIS INFORMATION, THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: INTENDED USE. ° ¿3 FRENCH STENTS ARE INDICATED FOR PEDIATRIC PATIENTS¿. PRECAUTIONS: ¿COMPLICATIONS OF URETERAL STENT PLACEMENT ARE DOCUMENTED IN LITERATURE. USE OF THIS DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PATIENT. INFORMED CONSENT SHOULD BE OBTAINED TO MAXIMIZE PATIENT COMPLIANCE WITH FOLLOW-UP PROCEDURES. ¿INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEMN ARE UNPREDICTABLE.¿ ¿PERIODIC EVALUATION VIA CYSTOSCOPIC, RADIOGRAPHIC, OR ULTRASONIC MEANS IS SUGGESTED.¿ ¿THE POTENTIAL EFFECTS OF PHTHALATES ON CHILDREN HAVE NOT BEEN FULLY CHARACTERIZED¿¿ ¿THE PATIENTS SHOULD BE INSTRUCTED IN TERMS THAT THEY UNDERSTAND TO INFORM THE PHYSICIAN IF THEY ARE EXPERIENCING ANY PAIN, CLOUDY URINE, BLADDER IRRITATION OR ANY SIGN OR SYMPTOMS THAT THEY ARE HAVING DIFFICULTY WITH URINATION.¿ ¿IF THE STENT IS PLACED IN A CHILD THE PARENTS SHOULD BE GIVEN THESE INSTRUCTIONS.¿ POTENTIAL ADVERSE EVENTS: ¿URINARY TRACTS INFECTION¿. INSTRUCTIONS FOR USE: WIRE GUIDE PREPARATION: ¿USING ASEPTIC TECHNIQUE, REMOVE THE WIRE FROM ITS OUTER PACKAGING AND PLACE IN THE STERILE FIELD.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES.¿ ¿STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED.¿ ¿DO NOT USE THE PRODUCT IF THERE IS A DOUBT AS TO WHETHER THE PRODUCT IS STERILE.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE INFECTION AND WHETHER IT WAS RELATED TO THE COOK PRODUCT USED AND THE CUSTOMER NOTED THAT THERE WAS NO DEVICE MALFUNCTION. IT WAS REPORTED THAT THE 6-YEARS-OLD PATIENT RECEIVED A 4.7 FRENCH STENT; HOWEVER, PER IFU, ¿3 FRENCH STENTS ARE INDICATED FOR PEDIATRIC PATIENTS¿ WHICH COULD HAD BEEN A POSSIBLE CAUSE BUT COULD NOT BE CONFIRMED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.