BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131615 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04262
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING NEEDLE PLUNGER DEPLOYMENT; HOWEVER, WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE, THE LINK BROKE AT THE SWAGE END OF THE POSTERIOR CUFF. A LINK BREAK DIRECTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE WHICH COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. LINK-TO-POSTERIOR CUFF DETACHMENT SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS FOR THE LINK-TO-POSTERIOR CUFF DETACHMENT DURING THE SUTURE RETRIEVAL PROCESS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES; HOWEVER, THE SUTURE WAS RETURNED INTACT AND THERE WAS NO INDICATION THAT IT WAS DRAGGED THROUGH THE DEVICE WHILE RETRACTING THE NEEDLE PLUNGER WHICH COULD CONTRIBUTE TO THE DETECTED LINK BREAK. ALSO, THERE WERE NO DAMAGES OBSERVED AT THE SUTURE BEARING TO SUGGEST THAT THE LINK OR SUTURE WAS DRAGGED THROUGH THE SUTURE BEARING WHICH COULD CAUSE THE LINK TO BREAK AT THE POSTERIOR CUFF. DURING TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. IN ADDITION, EVERY LINK ASSEMBLY IS PROOF-LOADED DURING MANUFACTURING. ANATOMICAL CONDITIONS; HOWEVER, THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS WHICH COULD CREATE RESISTANCE TO RETRACTING THE NEEDLE PLUNGER WHICH COULD CAUSE THE LINK TO BREAK. DEPLOYMENT TECHNIQUE; HOWEVER, THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGEST INCORRECT TECHNIQUE. THERE WAS NO INDICATION THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT WHICH COULD CAUSE THE LINK TO DETACH AT THE POSTERIOR CUFF. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENT THAT EXHIBITED A LINK BREAK AT THE POSTERIOR CUFF. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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-TEMECULA-CT 950246H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention