BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI STONE RETRVL PAIRED WIRE HELICAL BSKT

    MDR report key: 1813621 · Received August 25, 2010

    Report

    Report Number
    3005099803-2010-03534
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT, INCLUDING PROCEDURE DETAILS AND PATIEN'TS CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(6): ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A DEVICE WAS RECEIVED FOR THIS COMPLAINT, HOWEVER IT IS NOT A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET. HOWEVER, THE POUCH AND LABEL RETURNED MATCH THE COMPLAINT DESCRIPTION. THE RETURNED DEVICE IS NOT MANUFACTURED AT BSC-SPENCER, AND IT CANNOT BE DETERMINED IF THE DEVICE IS A BSC SALABLE PRODUCT. IT IS UNKNOWN HOW THE RETURNED PRODUCT WAS PAIRED WITH THE GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET PACKAGING. THE PHYSICIAN STATED THAT HE BELIEVED A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS RETURNED, AND DOES NOT KNOW WHY A DIFFERENT PRODUCT COULD HAVE BEEN RETURNED. BECAUSE THE GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS NOT RETURNED FOR ANALYSIS, THE COMPLAINT CANNOT BE CONFIRMED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE RETRIEVAL BASKET WAS POSITIONED IN THE PROXIMAL URETER TO CAPTURE THE STONE. HOWEVER, THE BASKET "CURLED IN A WEIRD FASHION" WHEN OPENED, AND THE TIP WAS "TRAPPED INSIDE THE WIRES MAKING IT IMPOSSIBLE TO RETRIEVE." THE BASKET WAS UNABLE TO CLOSE AT THIS POINT IN THE PROCEDURE. THE STONE, 5 TO 6 MM IN SIZE, HAD NOT BEEN CAPTURED WHEN THIS EVENT OCCURRED, AND NO PORTION OF THE BASKET DETACHED INSIDE THE PATIENT. NO LASER OR LITHOTRITE HAD BEEN USED. A LUMBOTOMY WAS PERFORMED, AND AN INVASIVE SURGERY WAS CARRIED OUT TO EXTRACT THE STONE AND THE RETRIEVAL BASKET. THE PATIENT EVOLUTIONED WITH URINE FILTERING THROUGH THE URETER 7 DAYS FROM THE SURGERY, WHICH WAS DRAINED PERCUTANEOUSLY. THE PATIENT IS REPORTED TO BE IN "GOOD CONDITIONS."

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE RETRIEVAL BASKET WAS POSITIONED IN THE PROXIMAL URETER TO CAPTURE THE STONE. HOWEVER, THE BASKET "CURLED IN A WEIRD FASHION" WHEN OPENED, AND THE TIP WAS "TRAPPED INSIDE THE WIRES MAKING IT IMPOSSIBLE TO RETRIEVE." THE BASKET WAS UNABLE TO CLOSE AT THIS POINT IN THE PROCEDURE. THE STONE, 5 TO 6 MM IN SIZE, HAD NOT BEEN CAPTURED WHEN THIS EVENT OCCURRED, AND NO PORTION OF THE BASKET DETACHED INSIDE THE PATIENT. NO LASER OR LITHOTRITE HAD BEEN USED. A LUMBOTOMY WAS PERFORMED, AND AN INVASIVE SURGERY WAS CARRIED OUT TO EXTRACT THE STONE AND THE RETRIEVAL BASKET. THE PATIENT EVOLUTIONED WITH URINE FILTERING THROUGH THE URETER 7 DAYS FROM THE SURGERY, WHICH WAS DRAINED PERCUTANEOUSLY. THE PATIENT IS REPORTED TO BE IN "GOOD CONDITIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 5, 2010 THAT A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE RETRIEVAL BASKET WAS POSITIONED IN THE PROXIMAL URETER TO CAPTURE THE STONE. HOWEVER, THE BASKET "CURLED IN A WEIRD FASHION" WHEN OPENED, AND THE TIP WAS "TRAPPED INSIDE THE WIRES MAKING IT IMPOSSIBLE TO RETRIEVE." THE PHYSICIAN "OPENED THE URETER" TO EXTRACT THE STONE AND THE RETRIEVAL BASKET. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS UNKNOWN. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRVL PAIRED WIRE HELICAL BSKT DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063301100 9425643

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention