BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP?

    MDR report key: 3212828 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-06125
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    A DETAILED DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ZERO TIP NITINOL BASKET; THE CONDITION OF THE DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET WAS BROKEN; HOWEVER, THE BASKET WIRES WERE NOT BROKEN AND WERE STILL ATTACHED AND PRESENT. THE BASKET WAS DETACHED AT THE SPLICE CANNULA AND THE DETACHED FRAGMENT WAS BENT. THE SHEATH SUB-ASSEMBLY WORKING LENGTH MEASURED BELOW THE LOWER SPECIFICATION LIMIT DUE TO THE TWISTED/BUCKLED SHEATH NEAR THE DISTAL END OF THE BLACK STRAIN. CRIMP MARKS WERE PRESENT ON THE SPLICE CANNULA TO INDICATE PROPER CRIMPING DURING MANUFACTURING. ADHESIVE RESIDUE WERE PRESENT IN THE SPLICE CANNULA AND PROXIMAL END OF THE DETACHED BASKET WIRE TO INDICATE THAT AN ADHESIVE WAS APPLIED DURING MANUFACTURING. THE DEVICES ARE 100% INSPECTED FOR FUNCTIONALITY/INTEGRITY DURING MANUFACTURING. THE MANUFACTURING IN-PROCESS PULL TEST SAMPLES ALL MET SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BASKET WAS USED INSIDE THE PATIENT AND GOT CAUGHT ON URETERAL ACCESS SHEATH AND BROKE WHEN TRYING TO REMOVE THE STONE FRAGMENTS. THE SURGEON USED A LASER DURING THE PROCEDURE BUT DID NOT COME INTO CONTACT WITH THE BASKET. THE COMPLAINANT FURTHER STATED THAT THERE WAS A STONE IN THE BASKET, APPROXIMATELY 4MM IN SIZE WHEN IT BROKE. THE REMAINING FRAGMENTS OF THE BASKET WERE RETRIEVED WITH A COOK N-SNARE AND ANOTHER ZERO TIP BASKET WAS USED TO FINISH THE CASE. REPORTEDLY, THE BASKET WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013.ACCORDING TO THE COMPLAINANT, THE BASKET WAS USED INSIDE THE PATIENT AND GOT CAUGHT ON URETERAL ACCESS SHEATH AND BROKE WHEN TRYING TO REMOVE THE STONE FRAGMENTS. THE SURGEON USED A LASER DURING THE PROCEDURE BUT DID NOT COME INTO CONTACT WITH THE BASKET. THE COMPLAINANT FURTHER STATED THAT THERE WAS A STONE IN THE BASKET, APPROXIMATELY 4MM IN SIZE WHEN IT BROKE. THE REMAINING FRAGMENTS OF THE BASKET WERE RETRIEVED WITH A COOK N-SNARE AND ANOTHER ZERO TIP BASKET WAS USED TO FINISH THE CASE. REPORTEDLY, THE BASKET WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313252 ZERO TIP? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050 16090418

    Patients

    Seq Age Sex Outcome Treatment
    1