BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM

    MDR report key: 7761494 · Received August 8, 2018

    Report

    Report Number
    2024168-2018-06080
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 18, 2018
    Report Date
    September 20, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LOT NUMBER CHANGED FROM 8040442 TO 8011542. IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNING FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO DEPLOY THE PLUNGER WAS NOT CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR ANALYSIS THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 8F SHEATH PRIOR TO A PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (PEVAR) PROCEDURE. REPORTEDLY, THE NEEDLE PLUNGER COULD NOT BE FULLY DEPLOYED. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 21F AND THE PEVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED 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
    603176 PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8011542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FHEPARIN| SHEATH: 8FHEPARIN