BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 17740808 · Received September 13, 2023

    Report

    Report Number
    1820334-2023-01232
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Report Date
    November 16, 2023
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002098435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: CUSTOMER NAME AND ADDRESS = (B)(6). G4: PMA/510(K) NUMBER = K171999. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, AT THE BEGINNING OF A MECHANICAL THROMBECTOMY PROCEDURE, A PERFORMER INTRODUCER LEAKED, AND THE SILICONE DISC WAS REPORTEDLY MISSING. LEFT FEMORAL ACCESS WAS OBTAINED TO TARGET THE PULMONARY ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. ANOTHER MANUFACTURER'S 12 FRENCH THROMBECTOMY DEVICE WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. ALTHOUGH BLEEDING WAS REPORTED, THE PATIENT DID NOT REQUIRE ANY INTERVENTION/TREATMENT FOR BLOOD LOSS. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND ON THE LOT. ONE OTHER COMPLAINT WAS NOTED ON THE LOT, FROM THE SAME CUSTOMER AND INVOLVING THE SAME FAILURE MODE. THERE WERE NO NON-CONFORMANCES OR ADDITIONAL COMPLAINTS FOUND ON THE SUB-ASSEMBLY LOT. THE PRODUCT IFU STATES ¿ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. BECAUSE ANOTHER MANUFACTURER¿S 12-FRENCH THROMBECTOMY DEVICE WAS REPORTEDLY USED THROUGH THE SHEATH, IT IS LIKELY THAT THE SILICONE DISC WAS ORIGINALLY PRESENT AND DISLODGED WHEN ANCILLARY DEVICES WERE PLACED THROUGH THE VALVE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    AS REPORTED, AT THE BEGINNING OF A MECHANICAL THROMBECTOMY PROCEDURE, A PERFORMER INTRODUCER LEAKED AND THE SILICONE DISC WAS REPORTEDLY MISSING. LEFT FEMORAL ACCESS WAS OBTAINED TO TARGET THE PULMONARY ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. ANOTHER MANUFACTURER'S 12 FRENCH THROMBECTOMY DEVICE WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. ALTHOUGH BLEEDING WAS REPORTED, THE PATIENT DID NOT REQUIRE ANY INTERVENTION/TREATMENT FOR BLOOD LOSS. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615197 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC 15367917 00827002098435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PENUMBRA- CAT12, 12FR