BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE

    MDR report key: 12779025 · Received November 9, 2021

    Report

    Report Number
    3005099803-2021-05800
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729121299
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED BY THE MATERIALS MANAGER. (B)(6). (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK E1: THIS EVENT WAS REPORTED BY THE MATERIALS MANAGER. THE PHYSICIAN PRESENT FOR THIS CASE WAS: (B)(6). DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF HOLE IN THE PACKAGING. BLOCK H10: THE RETURNED ESCAPE BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE POUCH WAS TORN IN ONE OF THE SIDES. THE UNIT DID NOT PRESENT ISSUES DUE TO WAS INSIDE OF THE ORIGINAL POUCH AND THE TRAY LOOKS CLOSED. NO OTHER ISSUES WAS NOTED. BASED ON ALL AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT. THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE, DESIGN OR USER ISSUE WHICH COULD HAVE CAUSED THE COMPLAINT. AS PER EXTERNAL SUPPORT FORM IT WAS CONCLUDED THAT THE MANUFACTURING PROCESS HAS ENOUGH CONTROLS TO ASSURE THE PRODUCT PERFORMANCE. MOST LIKELY PROCEDURAL FACTORS AS HANDLING OF THE DEVICE BOXES PRIOR TO USE, COULD HAVE LED TO THE REPORTED EVENT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE BASKET WAS UNPACKED ON (B)(6) 2021 FOR A URETEROSCOPY. DURING PREPARATION, A HOLE WAS NOTICED IN THE PACKAGING AND THE STERILITY OF THE DEVICE WAS COMPROMISED. ANOTHER ESCAPE BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE BASKET WAS UNPACKED ON (B)(6) 2021 FOR A URETEROSCOPY . DURING PREPARATION, A HOLE WAS NOTICED IN THE PACKAGING AND THE STERILITY OF THE DEVICE WAS COMPROMISED. ANOTHER ESCAPE BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680355 ESCAPE DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063902010 0025759741 08714729121299

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown