BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE AMPLATZ URETERAL STENT SET

    MDR report key: 14714199 · Received June 16, 2022

    Report

    Report Number
    1820334-2022-01078
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Report Date
    September 13, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K171603. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: H6- ANNEX A, ANNEX G. INVESTIGATION ¿ EVALUATION. AZ.OSP.'SAN GIOVANNI ADDOLORATA' (ITALY) INFORMED COOK ON 10JUN2022 OF AN ISSUE WITH 3 UTSSW-8.5-24-AMP-RH¿S (ULTRATHANE AMPLATZ URETERAL STENT SET) FROM UNKNOWN LOTS. THE CUSTOMER STATED THE DISTAL PART OF THE BLACK STENT TUBING OVERLAPPED THE PROXIMAL END OF THE STENT, CAUSING THE STENT TO BE UNABLE TO BE RELEASED. NO ADVERSE EFFECTS HAVE BEEN REPORTED. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU), 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 THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_AUSS_REV9] ¿AMPLATZ URETERAL STENT SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿PRECAUTIONS -DO NOT OVER-ADVANCE THE URETERAL STENT ONTO STENT POSITION. CRIMPING OF STENT COULD OCCUR. ¿INSTRUCTIONS FOR USE -LOAD THE NON-TAPERED PROXIMAL END OF THE URETERAL STENT ONTO THE DISTAL END OF THE PRE-ASSEMBLED STENT INTRODUCER. -HOLDING THE LOADING STYLET BEYOND THE TAPERED END OF URETERAL STENT INTRODUCER, LIGHTLY GRASP THE STENT ITSELF AND BEGIN ADVANCING THE NON-TAPERED PROXIMAL END OF THE STENT ONTO THE PRE-ASSEMBLED STENT INTRODUCER. ADVANCE THE STENT UNTIL ITS PROXIMAL END ALIGNS WITH AND COVERS THE RADIOPAQUE MARKER ON THE STENT INTRODUCER CATHETER. -REMOVE THE LOADING STYLET FROM THE PRE-ASSEMBLED STENT INTRODUCER. THE LOADING STYLET IS NOT TO BE USED FOR INTRODUCTION OF URETERAL STENT INTO THE PATIENT. -LOOSEN THE TUOHY-BORST ADAPTER AND POSITION THE DISTAL END OF THE STENT POSITIONER SO THAT IT ABUTS THE PROXIMAL END OF THE URETERAL STENT AT THE RADIOPAQUE MARKER. RETIGHTEN THE TUOHY-BORST ADAPTER. -ACTIVATE THE HYDROPHILIC COATING BY WETTING THE SURFACE OF THE DEVICE WITH STERILE WATER OR SALINE. FOR BEST RESULTS, MAINTAIN WETTED CONDITION OF THE DEVICE DURING PLACEMENT. THE URETERAL STENT IS NOW READY FOR INTRODUCTION. -INTRODUCE THE LOADED, PRE-ASSEMBLED STENT INTRODUCER OVER THE WIRE GUIDE THROUGH THE URETER INTO THE BLADDER. FINAL POSITION OF THE URETERAL STENT, PRIOR TO ACTUAL PLACEMENT, SHOULD BE VERIFIED BY FLUOROSCOPY OR RADIOGRAPHY. -TO RELEASE THE STENT FOR FINAL PLACEMENT: -LOOSEN THE TUOHY-BORST ADAPTER. -HOLDING THE SIDEARM FITTING OF THE STENT POSITION TO PREVENT INADVERTENT ADVANCEMENT OF THE STENT, SLOWLY PULL BACK AND REMOVE THE STENT INTRODUCER CATHETER FROM THE STENT POSITIONER. THE URETERAL STENT IS NOW POSITIONED AT ITS PREDETERMINED SITE. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE CAUSE OF EVENT TO BE UNINTENDED USER ERROR. THE CUSTOMER STATED THE DISTAL PART OF THE BLACK STENT TUBING OVERLAPPED THE PROXIMAL END OF THE STENT, CAUSING THE STENT TO BE UNABLE TO BE RELEASED. PER THE CURRENT PRODUCT IFU, IT STATES NOT TO OVER-ADVANCE THE STENT ONTO THE STENT POSITIONER AS IT COULD CRIMP THE STENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WAS EXPERIENCED WITH SEVERAL ULTRATHANE AMPLATZ URETERAL STENT SETS. A FEW TIMES OVER THE PAST SEVERAL YEARS, THE DISTAL PART OF THE STENT POSITIONER OVERLAPPED THE PROXIMAL PART OF STENT WHEN ADVANCING WITH FORCE TO PASS TIGHT STRICTURES. THIS RESULTED IN AN INABILITY TO RELEASE THE STENT. THE SYSTEMS WERE THEN REMOVED AND THE PROCEDURE WAS RESTARTED. NO ADVERSE EFFECTS WERE REPORTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130421 ULTRATHANE AMPLATZ URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown