BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 7947799 · Received October 9, 2018

    Report

    Report Number
    1820334-2018-03124
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    October 31, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002499741
    PMA / PMN Number
    K151051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. IMAGES OF X-RAYS OF THE DEVICE WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND THE INSTRUCTIONS FOR USE. THE DEVICE HISTORY RECORD WAS REVIEWED. IT WAS NOTED THERE ARE NO CONFORMANCES ASSOCIATED WITH THIS COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE LOT NUMBER 7140679. THE INSTRUCTIONS FOR USE (IFU) STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. ACCORDING TO THE PRECAUTIONS: THE UNIVERSA SOFT STENTS MUST NOT REMAIN INDWELLING MORE THAN 6 MONTHS. A PREGNANT PATIENT MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION DUE TO CALCIUM SUPPLEMENTS. INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND URINARY SYSTEM ARE UNPREDICTABLE. URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND/OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PATIENT'S CONDITION AND OTHER PATIENT SPECIFIC FACTORS. A CLINICAL ASSESSMENT OF THE COMPLAINT WAS CARRIED OUT. THE ENCRUSTATION CAN BE SEEN ON THE X-RAY. ENCRUSTATION IS A KNOWN INHERENT RISK OF THE DEVICE. AS INCLUDED IN THE INSTRUCTIONS FOR USE, PREGNANT PATIENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION, DUE TO THE USE OF CALCIUM SUPPLEMENTS. A CONCLUSION COULD NOT BE REACHED WITH THE AVAILABLE INFORMATION. HOWEVER AS INCLUDED IN THE INSTRUCTION FOR USE PREGNANT PATIENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION, DUE TO THE USE OF CALCIUM SUPPLEMENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND 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 · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THE PATIENT HAD ENDOSCOPY SURGERY FOR URETERAL STONES IN (B)(6) 2018. AS REPORTED, THE PATIENT CAME TO THE HOSPITAL BECAUSE SHE WAS HAVING BAD PAINS DUE TO KIDNEY STONE. WHEN SHE CAME TO THE HOSPITAL SHE WAS (B)(6). THE DOCTOR USED UNIVERSA SOFT URETERAL STENTS, BECAUSE THE STENT CAN LAST 6 MONTHS, MEANING AFTER SHE HAD THE BABY SHE CAN COME AGAIN FOR STENT REMOVAL. AFTER 4-MONTHS, THE PATIENT CAME BACK FOR A DOCTOR APPOINTMENT. SHE HAD AN X-RAY AND THE DOCTOR FOUND THE STENTS HAD ENCRUSTED. THE DOCTOR EXPLAINED TO THE PATIENT THAT SHE WOULD NEED TO HAVE AN OPERATION TO REMOVE THE STONE. A SECOND SURGERY WAS PERFORMED ON AN UNKNOWN DATE LASTING 3 HOURS REMOVING THE STENT, THAT WAS ENCRUSTED WITH A STONE. THE PHYSICIAN THEN MADE AN APPOINTMENT FOR PATIENT FOLLOW-UP FOR ONE-MONTH AS A RECHECK. AS REPORTED, A THIRD SURGERY MAY BE REQUIRED IF THE STONE OR ENCRUSTED CALCIUM STILL REMAINS IN THE BODY. NO FURTHER INFORMATION COULD BE OBTAINED. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANIES THIS DEVICE PROVIDES THE FOLLOWING PERTINENT INFORMATION: INTENDED USE: THE UNIVERSA SOFT URETERAL STENTS AND STENT SETS ARE USED FOR TEMPORARY INTERNAL DRAINAGE FROM THE URETEROPELVIC JUNCTION TO THE BLADDER. URETERAL STENTS HAVE BEEN USED TO RELIEVE OBSTRUCTION IN A VARIETY OF BENIGN, MALIGNANT AND POST-TRAUMATIC CONDITIONS. THE STENTS MAY BE PLACED USING ENDOSCOPIC, PERCUTANEOUS OR OPEN SURGICAL TECHNIQUES. PRECAUTIONS: THE POTENTIAL EFFECTS OF PHTHALATES ON PREGNANT/NURSING WOMEN OR CHILDREN HAVE NOT BEEN FULLY CHARACTERIZED AND THERE MAY BE CONCERN FOR THE REPRODUCTIVE AND DEVELOPMENTAL EFFECTS. THE UNIVERSA SOFT STENTS MUST NOT REMAIN INDWELLING MORE THAN SIX MONTHS. IF THE PATIENT¿S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT. A PREGNANT PATIENT MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION DUE TO CALCIUM SUPPLEMENTS. INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND /OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PATIENT¿S CONDITION AND OTHER PATIENT SPECIFIC FACTORS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE WHICH SHOULD NOT EXCEED 180 DAYS. USE OF THE DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PATIENT. POTENTIAL ADVERSE EVENTS: COMPLICATIONS OF URETERAL STENT PLACEMENT ARE DOCUMENTED. THESE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: EXTRAVASATIONS. OCCLUSION. MIGRATION. HEMORRHAGE. SEPSIS. PERFORATION OF THE URINARY TRACT. PERITONITIS. ENCRUSTATION. URINARY TRACT INFECTION. LOSS OF RENAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787625 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G49974 7140679 10827002499741

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other