BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 12956703 · Received December 7, 2021

    Report

    Report Number
    2024168-2021-11228
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 16, 2021
    Report Date
    January 31, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    USER FACILITY MEDWATCH #MW5106079.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. REPORTEDLY, THE PRECLOSE TECHNIQUE WAS NOT USED FOR A SHEATH GREATER THAN 8F. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE, STATES: FOR ARTERIAL AND VENOUS SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE ARE REQUIRED. IT IS UNKNOWN IF THE REPORTED VIOLATION OF THE IFU CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY USING TWO PROGLIDE DEVICES AFTER A PCI WITH EMERGENT IMPELLA PROCEDURE USING A 14F SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH THE FIRST PROGLIDE DEVICE. A SECOND PROGLIDE DEVICE WAS DEPLOYED. THE LEVER WAS RETURNED TO ITS ORIGINAL POSITION AND THE FOOT RETRACTED PRIOR TO DEVICE REMOVAL; HOWEVER, RESISTANCE WAS FELT DURING REMOVAL AND THE BLACK SHEATH SEPARATED FROM THE DEVICE. THE SEPARATED SHEATH WAS SNARED FROM THE CONTRALATERAL SIDE. THE PATIENT WAS SENT TO SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH RECEIVED STATES: "PERCLOSE DEVICE MALFUNCTION AND SHEARED OFF LEAVING A CATHETER PIECE IN THE PATIENT. SURGICAL INTERVENTION WAS REQUIRED FOR FOREIGN OBJECT REMOVAL." THE LOT NUMBER WAS REPORTED AS 1102241. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THE LOT NUMBER ON THE USER FACILITY MEDWATCH WAS LISTED INCORRECTLY. THE CORRECT LOT NUMBER WAS VERIFIED TO BE 1042241.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE DEVICE (VIA SNARE), CUT DOWN, ANGIOPLASTY AND SURGICAL SUTURING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854542 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 1042241 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN