BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B8634, UROWIRE SIX PACK 6/BX

    MDR report key: 12285172 · Received August 5, 2021

    Report

    Report Number
    2027111-2021-00595
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 13, 2021
    Report Date
    October 27, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    EZB
    PMA / PMN Number
    K944135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCT AND IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LASER STONE LITHOTRIPSY AND STENT REPLACEMENT. EVENT DESCRIPTION: THIS ISSUE HAPPENED ON BOTH (B)(6) 2021 AND AGAIN ON (B)(6) 2021 BUT WAS ONLY REPORTED TO APPLIED MEDICAL ON 30 JULY 2021. THE UROWIRE WAS USED WITH SALINE TO ACTIVATE THE HYDROPHILIC COATING. THE UROWIRE WAS PLACED INSIDE THE PATIENT AND THEN USED TO GUIDE THE FLEXIBLE URETEROSCOPE OVER THE GUIDE WIRE. ON INSPECTION THE SURGEON, [NAME], COULD SEE THAT THE UROWIRE WAS SHREDDING OR DELAMINATING INSIDE THE PATIENT. [NAME] MANAGED TO REMOVE ALL TRACES OF THE DELAMINATED PRODUCT FROM THE PATIENT AND FROM WITHIN THE FLEXIBLE URETEROSCOPE. THIS ISSUE HAPPENED TWICE, ONCE WITH A FLEXIBLE URETEROSCOPE AND ONCE WITH A RIGID URETEROSCOPE. THIS WAS ALL EXPLAINED TO ME BY TEAM LEADER AND NURSE, [NAME]. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] ON 02 AUGUST 2021: [NAME] CONTACTED ME TO SAY HE FOUND THE FAULTY B8634 PRODUCT. HOW CAN WE GO ABOUT TO ARRANGE COLLECTION? [NAME] WILL MAKE SURE IT IS CLEAN AND I AM ABLE TO DELIVER A "BIO-HAZARD" BAG TO PLACE THE PRODUCT IN. TYPE OF INTERVENTION: SURGEON MANAGED TO REMOVE ALL TRACES OF THE DELAMINATED PRODUCT FROM THE PATIENT AND FROM WITHIN THE FLEXIBLE URETEROSCOPE. PATIENT STATUS: THE PROCEDURE WAS COMPLETED AND THE PATIENT IS RECOVERING WELL.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT IS ANTICIPATED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE: LASER STONE LITHOTRIPSY AND STENT REPLACEMENT. THIS ISSUE HAPPENED ON BOTH (B)(6) 2021 AND AGAIN ON (B)(6) 2021 BUT WAS ONLY REPORTED TO APPLIED MEDICAL ON (B)(6) 2021. THE UROWIRE WAS USED WITH SALINE TO ACTIVATE THE HYDROPHILIC COATING. THE UROWIRE WAS PLACED INSIDE THE PATIENT AND THEN USED TO GUIDE THE FLEXIBLE URETEROSCOPE OVER THE GUIDE WIRE. ON INSPECTION THE SURGEON, [NAME], COULD SEE THAT THE UROWIRE WAS SHREDDING OR DELAMINATING INSIDE THE PATIENT. [NAME] MANAGED TO REMOVE ALL TRACES OF THE DELAMINATED PRODUCT FROM THE PATIENT AND FROM WITHIN THE FLEXIBLE URETEROSCOPE. THIS ISSUE HAPPENED TWICE, ONCE WITH A FLEXIBLE URETEROSCOPE AND ONCE WITH A RIGID URETEROSCOPE. THIS WAS ALL EXPLAINED TO ME BY TEAM LEADER AND NURSE, [NAME]. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] ON 02 AUGUST 2021: [NAME] CONTACTED ME TO SAY HE FOUND THE FAULTY B8634 PRODUCT. HOW CAN WE GO ABOUT TO ARRANGE COLLECTION? [NAME] WILL MAKE SURE IT IS CLEAN AND I AM ABLE TO DELIVER A "BIO-HAZARD" BAG TO PLACE THE PRODUCT IN. COMPLAINT (B)(4), COMPLAINT 1 OF 2. COMPLAINT (B)(4), COMPLAINT 2 OR 2. PATIENT STATUS: THE PROCEDURE WAS COMPLETED AND THE PATIENT IS RECOVERING WELL. TYPE OF INTERVENTION: SURGEON MANAGED TO REMOVE ALL TRACES OF THE DELAMINATED PRODUCT FROM THE PATIENT AND FROM WITHIN THE FLEXIBLE URETEROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176608 B8634, UROWIRE SIX PACK 6/BX STYLET FOR CATHETER, GASTRO UROLOGY EZB APPLIED MEDICAL RESOURCES B8634 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1