BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR

    MDR report key: 18955516 · Received March 21, 2024

    Report

    Report Number
    2024168-2024-03611
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 23, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648000621
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE TWO ADDITIONAL PROSTAR DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO FIRE WAS NOT CONFIRMED. UNUSED STERILE DEVICES WERE RETURNED FROM THE ACCOUNT. THE STERILE UNITS WERE VISUALLY AND FUNCTIONALLY TESTED WITH NO ANOMALIES NOTED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. FACTORS THAT MAY CONTRIBUTE TO THE REPORTED FAILURE TO DEPLOY THE NEEDLES MAY INCLUDE, BUT ARE NOT LIMITED TO, CHANGE POSITION OF DEVICE DURING DEPLOYMENT, DEVICE ORIENTATION, OVER INSERTION OF THE DEVICE. THE REPORTED DIFFICULTIES AND TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION: LOT # UPDATED FROM 3111441 TO 3090541. D4 CORRECTION: UDI# UPDATED FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO FIRE WAS NOT CONFIRMED. UNUSED STERILE DEVICES WERE RETURNED FROM THE ACCOUNT. THE STERILE UNITS WERE VISUALLY AND FUNCTIONALLY TESTED WITH NO ANOMALIES NOTED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. FACTORS THAT MAY CONTRIBUTE TO THE REPORTED FAILURE TO DEPLOY THE NEEDLES MAY INCLUDE, BUT ARE NOT LIMITED TO, CHANGE POSITION OF DEVICE DURING DEPLOYMENT, DEVICE ORIENTATION, OVER INSERTION OF THE DEVICE. THE REPORTED DIFFICULTIES AND TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION: LOT # UPDATED FROM 3111441 TO 3090541. D4 CORRECTION: UDI# UPDATED FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH THREE PROSTAR DEVICES RELATED TO AN INTERVENTIONAL PROCEDURE WITH A 10F SHEATH. REPORTEDLY, THE NEEDLE DID NOT LINE UP WITH THE OPENING FOR ALL THREE DEVICES. AN ADDITIONAL PROSTAR DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554881 PROSTAR DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12322-01 3090541 08717648000621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention