BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 16469542 · Received March 2, 2023

    Report

    Report Number
    1820334-2023-00207
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 8, 2023
    Manufacturer
    COOK VASCULAR INC
    Product Code
    FFL
    UDI-DI
    10827002482941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) IN THE LEFT KIDNEY, THE BASKET FROM AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT PROPERLY OPEN ON THE FIRST PASS AT EXTRACTING THE STONE. ANOTHER NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION: A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED. THE DEVICE WAS RETURNED IN OPEN PACKAGING TO COOK FOR INVESTIGATION. THE HANDLE CANNOT ACTUATE THE BASKET; NO DAMAGE IS VISIBLE. WHEN THE HANDLE WAS DISASSEMBLED, THE SAME RESULT HAPPENED WHEN TRYING TO MANUALLY ACTUATE BASKET. THE BASKET FORMATION APPEARS DAMAGED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LOT. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, COOK CONCLUDED THAT THE CAUSE FOR THE DAMAGE THAT WAS PREVENTING PROPER BASKET FUNCTIONING COULD NOT BE DETERMINED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CUSTOMER PHONE: (B)(6). CUSTOMER OCCUPATION: UNKNOWN. PMA/510(K) NUMBER: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    AS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) IN THE LEFT KIDNEY, THE BASKET FROM AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT PROPERLY OPEN ON THE FIRST PASS AT EXTRACTING THE STONE. ANOTHER NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914392 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK VASCULAR INC 14575362 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male FLEX 2, FUS, TERUMMO GUIDE WIRE