BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 5354850 · Received January 8, 2016

    Report

    Report Number
    2024168-2016-00099
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 13, 2015
    Report Date
    April 5, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER WAS UPDATED FROM 40521K1 TO 5081241. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION WHICH CONFIRMED THE RESISTANCE WITH THE GUIDE WIRE WHEN BACKLOADING THROUGH THE SHEATH. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE WERE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS ISSUE. ABBOTT CONDUCTED ROOT CAUSE ANALYSIS AND DURING FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA FOUND THE OCCURRENCE TO BE POTENTIALLY RELATED TO A MANUFACTURING ISSUE. CONTINUED ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES IS BEING PERFORMED. THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUNCTURE CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE GUIDE WIRE WOULD NOT PASS THROUGH THE PROGLIDE DEVICE. A SECOND PROGLIDE DEVICE WAS USED AND HEMOSTASIS WAS ACHIEVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. ALTHOUGH THE NAME OF THE PHYSICIAN WAS NOT PROVIDED, IT WAS REPORTED THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13277 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 5081241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention