BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONANCE STENT SET

    MDR report key: 12712433 · Received October 28, 2021

    Report

    Report Number
    3001845648-2021-00756
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    April 7, 2021
    Report Date
    March 16, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE RESONANCE STENT SET DEVICE OF UNKNOWN LOT # WAS NOT AVAILABLE FOR EVALUATION, THEREFORE A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. THE FOLLOWING COMPLAINTS WERE RAISED IN RELATION TO THIS LITERATURE PAPER: PR (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00768) - GAO 2021: MODERATE TO SEVERE OAB. PR (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00767) - GAO 2021: RECURRENT URINARY TRACT INFECTIONS. PR (B)(4) - GAO 2021: PAIN. PR (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00756) - GAO 2021: DISPLACEMENT/MIGRATION. PR (B)(4) (REPORT REFERENCE NUMBER - 3001845648-2021-00757) - GAO 2021: STENT ENCRUSTATION. AS THE LOT # OF THE RESONANCE STENT SET DEVICE IS UNKNOWN IT IS NOT POSSIBLE TO CARRY OUT A REVIEW OF THE MANUFACTURING RECORDS. HOWEVER, PRIOR TO DISTRIBUTION ALL RESONANCE STENT SET DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0020-18) STATES THE FOLLOWING: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: STENT DISLODGEMENT/MIGRATION.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE WHICH ACCOMPANY THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A PROCEDURAL RELATED EFFECT AS THE IFU WHICH ACCOMPANIES THIS DEVICE LISTS STENT DISLODGEMENT/MIGRATION AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORT, 1 PATIENT EXPERIENCED DISPLACEMENT. 1 PATIENT WITH THE RESONANCE STENT HAD MIGRATION, BUT INTERVENTION WAS NOT NECESSARY. NO OTHER ADVERSE EVENTS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE RESONANCE STENT SET DEVICE OF UNKNOWN LOT # WAS NOT AVAILABLE FOR EVALUATION, THEREFORE A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. THE FOLLOWING COMPLAINTS WERE RAISED IN RELATION TO THIS LITERATURE PAPER: PR 344554 - GAO 2021: MODERATE TO SEVERE OAB. PR 344559 - GAO 2021: RECURRENT URINARY TRACT INFECTIONS. PR 344560 - GAO 2021: PAIN. PR 344561 - GAO 2021: DISPLACEMENT/MIGRATION. PR 344562 - GAO 2021: STENT ENCRUSTATION. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE LOT # OF THE RESONANCE STENT SET DEVICE IS UNKNOWN IT IS NOT POSSIBLE TO CARRY OUT A REVIEW OF THE MANUFACTURING RECORDS. HOWEVER, PRIOR TO DISTRIBUTION ALL RESONANCE STENT SET DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0020-18) STATES THE FOLLOWING: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: STENT DISLODGEMENT/MIGRATION.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE WHICH ACCOMPANY THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A PROCEDURAL RELATED EFFECT AS THE IFU WHICH ACCOMPANIES THIS DEVICE LISTS STENT DISLODGEMENT/MIGRATION AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORT, 1 PATIENT EXPERIENCED DISPLACEMENT. 1 PATIENT WITH THE RESONANCE STENT HAD MIGRATION, BUT INTERVENTION WAS NOT NECESSARY. NO OTHER ADVERSE EVENTS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    GAO, 2021, THE RESONANCE AND THE ALLIUM URETERAL STENTS IN THE TREATMENT OF NON-MALIGNANT REFRACTORY URETEROSTENOSIS. 18 PATIENTS UNDERWENT THE PROCEDURE USING A RESONANCE STENT. INTRAOPERATIVE PLACEMENT OF URETERAL STENTS WAS USUALLY UNDER FLUOROSCOPIC GUIDANCE. FOR RESONANCE STENTS, 24 CM ONES WERE CHOSEN FOR PATIENTS SHORTER THAN 165 CM, 26 CM FOR PATIENTS BETWEEN 165 AND 175 CM, AND 28 CM FOR PATIENTS TALLER THAN 175 CM. RESONANCE STENTS WERE REPLACED YEARLY. 1 PATIENT EXPERIENCED DISPLACEMENT. 1 PATIENT WITH THE RESONANCE STENT HAD MIGRATION, BUT NOT NECESSARY FOR INTERVENTION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE A CORRECTION TO UPDATE THE FAILURE MODE CODING ON 16-MAR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608365 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male