BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 12046790 · Received June 22, 2021

    Report

    Report Number
    2024168-2021-05309
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    December 15, 2020
    Report Date
    August 17, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED UNSPECIFIED FAILURE MODE WAS OBSERVED AS A POSTERIOR NEEDLE TO CUFF MISS AND LINK DETACHMENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. SIMILAR INCIDENT REVIEW COULD NOT BE COMPLETED AS SIMILARITY COULD NOT BE DETERMINED BECAUSE A SPECIFIC FAILURE MODE WAS NOT PROVIDED. ALTHOUGH A SPECIFIC FAILURE MODE WAS NOT PROVIDED, THE RETURNED DEVICE CONDITION INDICATES A POSTERIOR NEEDLE TO CUFF MISS AND LINK DETACHMENT OCCURRED. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED AS INFORMATION REGARDING THE DEVICE RECEIVED WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.B3: ESTIMATED DATE OF EVENT: B5, B6 AND B7. H6: REMOVED COMPONENT CODE 4755. H6: REMOVED INVESTIGATION CONCLUSION CODE 18. H10: REMOVED USE PAST EXPIRATION STATEMENT.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED UNSPECIFIED FAILURE MODE WAS OBSERVED AS A POSTERIOR NEEDLE TO CUFF MISS AND LINK DETACHMENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ALTHOUGH A SPECIFIC FAILURE MODE WAS NOT PROVIDED, THE RETURNED DEVICE CONDITIONS INDICATES A POSTERIOR NEEDLE TO CUFF MISS AND LINK DETACHMENT OCCURRED. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED AS INFORMATION REGARDING THE FOUR ADDITIONAL DEVICES RECEIVED WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. REVIEW OF THE LABELS ATTACHED TO THE DEVICE HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND LABEL INDICATED AN EXPIRATION DATE (USE BY DATE) OF (B)(6) 2020 AND THE PROCEDURE DATE WAS (B)(6) 2021 WHICH IS APPROXIMATELY 2 MONTHS POST EXPIRATION. IT SHOULD BE NOTED THE PROGLIDE INSTRUCTIONS FOR USE (IFU), IN THE GRAPHICAL SYMBOLS FOR MEDICAL DEVICE LABELING SECTION INDICATES THE USE BY SYMBOL WHICH IS THE NEXT TO THE EXPIRATION DATE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED: NONE OF THE ADDITIONAL RETURNED PROGLIDE DEVICES THAT HAD BEEN RETURNED ARE ASSOCIATED WITH THE INITIALLY REPORTED PROCEDURE THAT OCCURRED ON (B)(6) 2021. THIS EVENT REPORTS THE RETURNED DEVICE FOR A PERCLOSE PROGLIDE, LOT# 9020141. THIS RETURNED DEVICE ISSUE WAS DETERMINED TO HAVE OCCURRED DURING A SEPARATE PROCEDURE ON AN UNKNOWN DATE. THERE WAS OTHER NO REPORTED INFORMATION ON THIS COMPLAINT DEVICE. ANALYSIS OF THE RETURNED DEVICE FOUND THE SUTURE WAS PULLED OUT OF THE DEVICE BUT REMAINED IN THE POSTERIOR FOOT AREA. A DEVICE IN THIS CONDITION WOULD NOT HAVE ACHIEVED HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 7F SHEATH PRIOR TO AN A ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. THE SELDINGER TECHNIQUE WAS USED WITH A .035 X 260 CM HYDROPHILIC GUIDE WIRE. REPORTEDLY, THERE WAS NO SUTURE PRESENT WHEN THE NEEDLE PLUNGER WAS REMOVED AFTER DEPLOYMENT. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED IN THE RCFA. THE SHEATH WAS UPSIZED TO A 22F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES IN THE RCFA. ADDITIONALLY, THE SUTURES OF TWO PROGLIDES HAD BEEN SUCCESSFULLY PRE-PLACED AND USED TO ACHIEVE HEMOSTASIS SUCCESSFULLY IN THE LEFT COMMON FEMORAL ARTERY (LCFA). THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENTLY, FOUR ADDITIONAL PROGLIDE DEVICES WERE RECEIVED RELATED TO THIS EVENT WITH NO REPORTED INFORMATION AVAILABLE. ANALYSIS OF THE RETURNED PROGLIDE DEVICES NOTED THAT THERE WAS BLOOD IN AND ON THE PROGLIDE DEVICES. THREE HAD LINK BREAKS AND ONE HAD THE SUTURE PULLED OUT OF THE DEVICE. DEVICES IN THIS CONDITION WOULD NOT HAVE ACHIEVED HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942514 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 9020141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention