BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 17145055 · Received June 16, 2023

    Report

    Report Number
    1820334-2023-00768
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 28, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, A SOF-FLEX MULTI-LENGTH URETERAL STENT THAT WAS IN SITU FOR FOUR WEEKS, WAS DISCOVERED KNOTTED. THERE WERE A FEW STONE FRAGMENTS DISTAL TO THE STENT KNOT IN THE PROXIMAL URETER, APPROXIMATELY 4 CM BELOW THE PELVIC URETERIC JUNCTION (PUJ). THEY WERE UNAWARE THAT THE STENT WAS KNOTTED AT THE PROXIMAL END OF THE STENT AND ATTEMPT TO REMOVE THE STENT VIA A RIGID URETEROSCOPY, WHICH WAS UNSUCCESSFUL. THEY THEN TRIED TO REMOVE THE STENT VIA FLEXIBLE PYELOSCOPY, WHICH WAS ALSO UNSUCCESSFUL. EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) WAS THEN PERFORMED ON THE PROXIMAL END OF THE STENT WITH 1000 SHOCKS AND THE STENT WAS REMOVED WITH A LITTLE BIT OF EXTRA FORCE. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INVESTIGATION EVALUATION: INTERVIEWING PERSONNEL ALONG WITH REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK WAS UNABLE TO COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS DEVICE AS THE LOT NUMBER WAS UNKNOWN. A TRACKWISE SEARCH FOR ADDITIONAL CUSTOMER COMPLAINTS ASSOCIATED WITH THE STENT SET LOT WAS ALSO UNABLE TO BE COMPLETED. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [T_SFMUS_REV1; 'SOF-FLEX MULTI-LENGTH URETERAL STENT SET'] SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: "WARNINGS: FORMATION OF KNOTS IN MULTI-LENGTH STENTS MAY OCCUR. THIS MAY RESULT IN INJURY TO THE URETER DURING REMOVAL AND/OR THE NEED FOR ADDITIONAL SURGICAL INTERVENTION. THE PRESENCE OF A KNOT SHOULD BE CONSIDERED IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING ATTEMPTS AT REMOVAL.¿ THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED. HOWEVER, THE CUSTOMER PROVIDED TWO PHOTOS OF THE REMOVED STENT WHICH SHOWED THE PRESENCE OF A KNOT; THE COMPLAINT WAS CONFIRMED BASED ON THIS PHOTO. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. HOWEVER, THIS IS A KNOWN RISK ASSOCIATED WITH THIS TYPE OF DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING 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.

    Additional Manufacturer Narrative · 0

    E1: NAME AND ADDRESS: POSTAL CODE: (B)(6). G4: PMA/510K#: K180053. 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 · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    AS REPORTED, A SOF-FLEX MULTI-LENGTH URETERAL STENT THAT WAS IN SITU FOR FOUR WEEKS, WAS DISCOVERED KNOTTED. THERE WERE A FEW STONE FRAGMENTS DISTAL TO THE STENT KNOT IN THE PROXIMAL URETER, APPROXIMATELY 4 CM BELOW THE PELVIC URETERIC JUNCTION (PUJ). THEY WERE UNAWARE THAT THE STENT WAS KNOTTED AT THE PROXIMAL END OF THE STENT, AND ATTEMPT TO REMOVE THE STENT VIA A RIGID URETEROSCOPY, WHICH WAS UNSUCCESSFUL. THEY THEN TRIED TO REMOVE THE STENT VIA FLEXIBLE PYELOSCOPY, WHICH WAS ALSO UNSUCCESSFUL. EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) WAS THEN PERFORMED ON THE PROXIMAL END OF THE STENT WITH 1000 SHOCKS AND THE STENT WAS REMOVED WITH A LITTLE BIT OF EXTRA FORCE. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014573 SOF-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention RIGID URETEROSCOPY, FLEXIBLE PYELOSCOPE