BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904513 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02941
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE WAS OMITTED ON FOLLOW-UP MEDWATCH REPORT FILED ON (B)(4) 2010. INCORRECT ANATOMY - NOT THE COMMON FEMORAL ARTERY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED;THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.DEVICES #1 AND #2: PROGLIDE (PART #12673-03; LOT #UNK), ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 4199ML. THE FILL VOLUME WAS 2200ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011 REGARDING THE IIPV. ACCORDING TO THE NURSE SHE IS AWARE THAT THE PATIENT HAS BEEN HAVING ISSUES WITH DRAINS, HOWEVER, SHE WAS NOT AWARE OF THE PATIENT'S HIGH ULTRAFILTRATION. THE NURSE STATED THAT THE PATIENT HAD HER CATHETER REPOSITIONED YESTERDAY. THE NURSE WILL CONTINUE TO MONITOR THE PATIENT'S DRAINS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED DEVICE FAILURE OCCURRED. THE DEVICE WAS REMOVED AN A SECOND AND THIRD PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. THE PUNCTURE SITE WAS BORDERLINE HIGH AT APPROXIMATELY THE TAKE OFF OF THE INFERIOR EPIGASTIC ARTERY. AFTER THE DEVICES WERE REMOVED A LARGE DISSECTION IN THE AREA OF THE PUNCTURE SITE WAS NOTICED. ANGIOPLASTY BALLOONING WAS PERFORMED UNSUCCESSFULLY TO TREAT THE DISSECTION. ARTERIAL SURGICAL REPAIR IS PLANNED; HOWEVER, EXACT DATE OF SURGERY IS UNKNOWN. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention