BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2021757 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00847
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. IF RECEIVED AND UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE FOUND THE BASKET WOULD OPEN AND CLOSE WITHOUT ANY ISSUES. THE BASKET WOULD FUNCTION WITH THE DEVICE HELD STRAIGHT AND WHEN HELD IN A LOOP. ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED; HOWEVER, THE BASKET WIRES WERE NOT EVENLY SPACED WHEN OPENED. KINKS WERE FOUND ALONG THE OUTER SHEATH; THESE KINKS DID NOT IMPACT THE ABILITY OF THE BASKET TO FUNCTION. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT EXIST TO LIMIT PRODUCT PERFORMANCE ISSUES. HOWEVER, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. ADDITIONALLY, A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. BASED ON THE DEVICE EVALUATION RESULTS THIS COMPLAINT IS NO LONGER CONSIDERED A REPORTABLE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION BY THE COMPLAINANT THAT THERE WAS AN ISSUE WITH A ZERO TIP NITINOL STONE RETRIEVAL BASKET ON (B)(6), 2011. IT COULD NOT BE OBTAINED WHAT THE ISSUE WAS NOR HOW THE PROCEDURE WAS COMPLETED, HOWEVER IT WAS REPORTED THAT IT OCCURRED OUTSIDE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION BY THE COMPLAINANT THAT THERE WAS AN ISSUE WITH A ZERO TIP NITINOL STONE RETRIEVAL BASKET ON (B)(6), 2011. IT COULD NOT BE OBTAINED WHAT THE ISSUE WAS NOR HOW THE PROCEDURE WAS COMPLETED, HOWEVER IT WAS REPORTED THAT IT OCCURRED OUTSIDE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050 13931554

    Patients

    Seq Age Sex Outcome Treatment
    1