BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 8628326 · Received May 21, 2019

    Report

    Report Number
    1820334-2019-01168
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    May 4, 2019
    Report Date
    June 12, 2019
    Manufacturer
    COOK INC
    Product Code
    EZN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SEE EVENT. ADDITIONAL INFORMATION: EVENT. TYPE OF REPORTABLE EVENT: OUR SYSTEM REQUIRES THIS FIELD TO BE POPULATED AND STILL REFLECTS "SERIOUS INJURY" THERE WAS NO SERIOUS INJURY. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP MDR WILL NOT BE SUBMITTED, AS THIS NO LONGER MEETS THE DEFINITION OF A MDR REPORTABLE EVENT. 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

    ADDITIONAL INFORMATION PROVIDED ON 22MAY2019. A FOLLOW-UP CT SCAN SHOWS NO INJURY TO THE URETER. THE PATIENT IS ASYMPTOMATIC. "IT MUST HAVE BEEN A MUCOSAL FLAP THAT WAS DIFFICULT TO IDENTIFY". THERE WAS NO ALLEGATION OR EVIDENCE OF DEVICE MALFUNCTION. IT WAS INITIALLY REPORTED THAT THEY HAD EVERTED THE URETERAL ORIFICE AND THIS WAS INCORRECTLY REPORTED AS A PRODUCT PROBLEM AND ADVERSE EVENT ON THE INITIAL MDR. IT SHOULD HAVE BEEN REPORTED AS AN ADVERSE EVENT (SERIOUS INJURY) ONLY. ADDITIONAL INFORMATION RECEIVED INDICATES THERE WAS NO DAMAGE TO THE URETER AND THEREFORE NO SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    COMMON NAME/PRO CODE: EXACT RPN UNKNOWN-EITHER FED (ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY) OR KOE; EZN (ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY; DILATOR, CATHETER, URETERAL). PMA/510K # : EXACT RPN UNKNOWN-EITHER K043418 OR K961904. (B)(4). 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 DURING A URETEROSCOPY ON A (B)(6) MALE (WITH A PRE-EXISTING STENT) USING A FLEXOR PARALLEL URETERAL ACCESS SHEATH, THE PHYSICIAN PLACED A GUIDE WIRE UP TO THE KIDNEY, THEN PLACED THE ACCESS SHEATH "ONCE PHYSICIAN REMOVED OBTURATOR THE ACCESS SHEATH POPPED OUT OF THE PATIENT". THE PHYSICIAN WENT BACK INTO THE BLADDER BUT COULDN'T GET BACK UP TO THE KIDNEY AGAIN. IT WAS THEN OBSERVED THAT THEY HAD EVERTED THE URETERAL ORIFICE. THE PHYSICIAN STATED THAT THEY MIGHT HAVE CAUGHT THE LIP OF THE SHEATH ON THE URETERAL ORIFICE CONTRIBUTING TO THIS ISSUE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AFTER THIS DIFFICULTY WAS EXPERIENCED. IT WAS REPORTED THAT THE PHYSICIAN WAS CONSIDERING AT CT SCAN TO ASSESS FOR DAMAGE TO THE URETER, AT THE TIME OF THE REPORT, THIS HAD NOT YET BEEN COMPLETED. NO OTHER CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. ADDITIONAL DETAILS REGARDING THE PATIENT AND THE EVENT HAS BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421358 FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS EZN COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other HC GLIDEWIRE| HC GLIDEWIRE