BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19533403 · Received June 13, 2024

    Report

    Report Number
    2024168-2024-07135
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 21, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648216022
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED ANALYSIS. THE REPORTED DIFFICULTY DEPLOYING THE PLUNGER WAS NOT CONFIRMED. THE REPORTED LINK BREAK WAS OBSERVED AS A NEEDLE TO CUFF MISS. 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 OF SPECIFIC QUALITY ISSUE. REPORTEDLY, A FEMORAL IMAGING WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE, STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. IN THIS CASE, THE OBSERVATIONS INDICATE ANATOMICAL CONDITION, EXCESSIVE DOWNWARD FORCE AND/OR FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT CAUSED THE NEEDLE TO DEFLECT STRIKING/SMASHING THE CUFF RESULTING IN THE FAILURE TO FULLY DEPLOY THE PLUNGER, NOTED NEEDLE TO CUFF MISS AND DAMAGES. THE TREATMENT APPEARS TO BE RELATED TO THE 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. CORRECTIONS: D1 ¿ BRAND NAME: UPDATED. D2A ¿ COMMON DEVICE NAME: UPDATED. D3 ¿ NAME, ADDRESS 1, CITY, POSTAL CODE: UPDATED. D4 - LOT #: UPDATED FROM 3052541 TO 3052341. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 5/25/2023 TO 5/23/2023. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 1142 WAS REMOVED AND CODES 2983 AND 1562 WERE ADDED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: DEVICE CODE 2017- FAILURE TO FOLLOW STEPS / INSTRUCTIONS.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: REPORTEDLY, THE PROGLIDE DEVICE WAS ADVANCED TO THE FEMORAL ARTERY. STEP 1 WAS COMPLETED, HOWEVER, DURING STEP 2 THE PHYSICIAN DEPRESS THE PLUNGER, BUT THE PLUNGER COULD NOT BE DEPRESSED. THE DEVICE WAS REMOVED, AND INSPECTED, AND A LINK BREAK WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE AFTER A NEURO INTERVENTIONAL PROCEDURE USING AN 8F SHEATH. FEMORAL IMAGING WAS NOT PERFORMED. REPORTEDLY, THE SUTURE WAS NOT PRESENT WHEN THE PLUNGER WAS REMOVED (A CUFF MISS OCCURRED). THE DEVICE WAS REMOVED AND THE FOOT PLATE WAS OPENED POST PROCEDURE. A NEW PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937221 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673 3052341 08717648216022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention