BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAYLIS MED TECH PASSPORT STEERABLE SHEATH

    MDR report key: 24161251 · Received January 23, 2026

    Report

    Report Number
    1035166-2026-00002
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    March 30, 2026
    Manufacturer
    INTEGER
    Product Code
    DYB
    UDI-DI
    00885672012595
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. INTEGER IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY INTEGER WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, B5, G1, G6, H2, H6 & H11. NO PRODUCT WAS RETURNED TO INTEGER FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, INTEGER IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. THE CUSTOMER STATED MASSIVE HEMATOMAS REQUIRING PATIENT TO GO TO OR FOR OPEN REPAIR OF ARTERY. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE IFU LIST HEMATOMA FORMATION AS A POSSIBLE ADVERSE EVENT. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IFU INSTRUCTIONS FOR USE (IFU) INFORMS THE USER PER BM-17-001Z-X: PREPARING STEERABLE SHEATH FOR INSERTION: VERIFY DEFLECTING AND STRAIGHTENING OF THE DISTAL SECTION OF THE STEERABLE SHEATH USING THE HANDLE OF THE SHEATH. REFER TO DEFLECTING AND STRAIGHTENING THE STEERABLE SHEATH" FOR INSTRUCTIONS. POTENTIAL ADVERSE EFFECTS RELATED TO THE USE OF THE STEERABLE SHEATH INCLUDE HEMATOMA FORMATION. INTEGER IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY INTEGER WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM SALES ON 31-DEC-2025: CUSTOMER REPORTED HEMATOMA FORMATIONS IN (3) SEPARATE PATIENTS WHEN USING THE PASSPORT TD CURVE, THE COMPLAINT HAS BEEN ELEVATED TO THE ADMINISTRATION OF THE QUALITY AND SAFETY STAFF AT (B)(6) HOSPITAL. "THIS IS OUR 3RD FAILURE OF THIS PRODUCT WHICH RESULTED IN MASSIVE HEMATOMAS REQUIRING TWO PATIENTS TO GO TO OR FOR OPEN REPAIR OF ARTERY. ALL 3 FAILURES WERE FOR A 9MM SHEATH W/2 VERY NOTABLE EXTRAVAGATION EVENTS. DIFFERENT PHYSICIAN USERS. WE NEED AN EVALUATION OF THE DEVICE BY VENDORS AND FOR THEM TO MEET WITH OUR PHYSICIANS TO SEE IF THIS IS AN INTRODUCER ERROR OR SHEATH ERROR. PRODUCTS WERE NOT RETAINED FOLLOWING THE PROCEDURE DUE TO URGENT NEED TO TRANSITION PATIENT TO OR SUITES." "THE SAME LOT NUMBER FOR ALL 3 PATIENTS". ASSOCIATED COMPLAINTS: (B)(4).

    Description of Event or Problem · 0

    28/JAN/2026 FEEDBACK FROM BAYLIS RECEIVED: OUR SALES TEAM IS IN COMMUNICATION WITH THE HOSPITAL REGARDING THE RETURN. IF THEY HAVE AN UPDATE I WILL EMAIL YOU PROMPTLY. 11/FEB/2026 CUSTOMER REPORTED: THE ADDITIONAL INFORMATION REQUESTED IS UNFORTUNATELY NOT AVAILABLE FROM THE CUSTOMER AND WILL NOT BE ABLE TO BE PROVIDED. THE PRODUCT IS ALSO NOT AVAILABLE FOR RETURN. EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46344 BAYLIS MED TECH PASSPORT STEERABLE SHEATH INTRODUCER, CATHETER DYB INTEGER PSS0705509TD S9762993 00885672012595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention