BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE BLUE 0.7M 60CM W/NDL

    MDR report key: 8704075 · Received June 17, 2019

    Report

    Report Number
    2210968-2019-82804
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 17, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE WAS NO SAMPLE RECEIVED FOR ANALYSIS. ONLY A PICTURE OF THE SAMPLE WAS RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION OF THE PICTURE,A BROKEN SUTURE COULD BE OBSERVED. HOWEVER, NO CONCLUSION COULD BE REACH AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH MEJ953 AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 1. WHICH LAYER OF TISSUE WAS EACH LAYER OF THE 6-0 PROLENE SUTURE USED ON? : ASD WALL TISSUE (ATRIAL WALL) 2. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? : NORMAL AND HEALTHY. PHOTOS HAVE BEEN SHARED BY THE SURGEON. 3. DID THE SURGEON OBSERVE ANY ANOMALY OR DEFICIENCY OF THE PROLENE SUTURE BEFORE OR DURING USE? : NO ANOMALY OR DEFICIENCY OBSERVED IN THE PROLENE SUTURE BEFORE OR DURING USE 4. HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? : MULTIPLE KNOTS 5. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS : NO RELEVANT PATIENT HISTORY MENTIONED BY SURGEON 6. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? : POOR SUTURE QUALITY 7. CAN YOU IDENTIFY THE LOT NUMBER OF THE 6-0 PROLENE W8718 SUTURE? : MEJ953 8. DO YOU HAVE ANY SUTURE AVAILABLE FOR RETURN OR REPRESENTATIVE SAMPLES FROM THE SAME LOT? : YES, I HAVE RECEIVED A SAMPLE OF THE SAME LOT FROM THE OT. LET ME KNOW WHERE TO SEND IT. 9. WHAT IS THE PATIENT¿S CURRENT STATUS? : PATIENT IS RECOVERING NOW. SECOND DEVICE CAPTURED IN MW 2210968-2019-82805.

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE EVALUATION SUMMARY: AN UNOPENED SAMPLE OF PRODUCT CODE W8718, LOT# MEJ953 WAS RETURNED FOR EVALUATION. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE SAMPLE, NO DEFECTS WERE FOUND ON THE PACKAGE. THE SAMPLE WAS OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURE WAS DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE REPRESENTATIVE SAMPLE, NO PERFORMANCE - BREAKAGE SUTURE POST-OP WAS FOUND AND THE TESTED SAMPLE MET THE FINISHED GOODS REQUIREMENTS. REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF 2 DEVICE ISSUES CAPTURED IN REPORTS MW 2210968-2019-82804 AND 2210968-2019-82805. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW-UP REPORTS FOR EACH. SECOND DEVICE CAPTURED IN MW 2210968-2019-82804.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHICH LAYER OF TISSUE WAS EACH LAYER OF THE 6-0 PROLENE SUTURE USED ON? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? DID THE SURGEON OBSERVE ANY ANOMALY OR DEFICIENCY OF THE PROLENE SUTURE BEFORE OR DURING USE? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? CAN YOU IDENTIFY THE LOT NUMBER OF THE 6-0 PROLENE W8718 SUTURE? DO YOU HAVE ANY SUTURE AVAILABLE FOR RETURN OR REPRESENTATIVE SAMPLES FROM THE SAME LOT? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART ASD REPAIR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS USED ON THE AUTOLOGOUS PERICARDIAL PATCH. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. THE POSTOPERATIVE AND SUBSEQUENT PRE-DISCHARGE ECHOCARDIOGRAMS SHOWED INTACT ASD PATCH WITHOUT ANY RESIDUAL SHUNT ACROSS THE PATCH. TEN DAYS AFTER THE DISCHARGE, WHEN THE CHILD CAME FOR FOLLOW-UP EXAMINATION, THE ECHOCARDIOGRAM SHOWED OPENED UP ASD PATCH, LARGE LEFT TO RIGHT SHUNT ACROSS ASD AND FREE HANGING PERICARDIAL PATCH ATTACHED TO ASD MARGIN AT ONE PLACE. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2019 AND IT WAS NOTED THAT THE PERICARDIAL PATCH AND THE ASD MARGIN WERE FRESH AND HEALTHY WITHOUT EVIDENCE OF INFECTION AND DETACHMENT OR RUGGED EDGES. THE PATCH WAS ATTACHED TO ASD MARGIN ONLY AT THE SITE WHERE CONTINUOUS SUTURE WAS TIED, THE KNOT AND ADJACENT SUTURE WAS INTACT. THE SUTURE WAS FOUND TO BE BROKEN FAR AWAY FROM THE KNOT AND THE LOOSE END WAS FOUND FREE IN THE CAVITY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499640 PROLENE BLUE 0.7M 60CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. MEJ953

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention