BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE SUTURE 30"(75CM) 4-0 BLU

    MDR report key: 20153914 · Received September 5, 2024

    Report

    Report Number
    2210968-2024-09344
    Event Type
    Injury
    Date Received
    September 5, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031021549
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS PREJET? IS IT PART OF THE SUTURE? IT WAS TYPO FOR PREDGET WAS AN ETHICON PLEDGET USED IN CONJUNCTION WITH THE PROLENE SUTURE? IF YES, PLEASE SPECIFY. YES. PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. UNK. DATE OF INDEX SURGICAL PROCEDURE? UNK. ON WHAT TISSUE WAS THE SUTURE USED? RIGHT MAIN BRONCHUS MEMBRANOUS PORTION. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? NOT REPORTED DIRECTLY, BUT HE HAD CANCER AND TERRIBLE SMOKING HABIT FOR LONG TIME. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? INTERRUPTED. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? UNK. PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). BLOODY SPUTUM AND WHEEZING PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. POST-OP 15 MONTHS. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NO. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? POST-OP. WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. UNK. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? UNK. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS.¿TRANEXAMIC ACID, ANTIALLERGIC DRUGS, STEROIDS WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. NO. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? NO. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNK. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? RECOVERED. LOT NUMBER? UNK.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. WHAT IS PREJET? IS IT PART OF THE SUTURE? WAS AN ETHICON PLEDGET USED IN CONJUNCTION WITH THE PROLENE SUTURE? IF YES, PLEASE SPECIFY. PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE OF INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CHEST OF RIGHT UPPER LOBECTOMY FOR RIGHT UPPER LOBE LUNG ADENOCARCINOMA (STAGE 2B) ON AN UNKOWN DATE AND SUTURE WAS USED. DURING THE OPERATION, 2 CENTIMETERS OF THE RIGHT MAIN BRONCHIAL OF THE MEMBRANOUS PORTION WAS INJURED BY DISSECTING FORCEPS DURING PERIBRONCHIAL DISSECTION, AND THE INJURED AREA WAS REPAIRED BY 2 STITCHES WITH SUTURE WITH A PREJET. AFTERWARDS, IT WAS COVERED WITH A FACTOR XIII WITH FIBRINOGEN FORMULATION AND A POLYGLYCOLIC ACID SHEET. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE, BUT ABOUT 1 YEAR AND 3 MONTHS AFTER SURGERY, A BLOODY SPUTUM APPEARED. TRANEXAMIC ACID ADMINISTRATION CAUSED REMISSION, BUT ABOUT 1 YEAR AND 5 MONTHS AFTER SURGERY, THE BLOODY SPUTUM RELAPSED AND WHEEZING WAS ALSO RECOGNIZED, SO BRONCHOSCOPY WAS EXAMINED. AS A RESULT, PREJET AND SUTURE WERE EXPOSURE, AND HEMORRHAGIC FORMATION OF GRANULOMA WERE RECOGNIZED AT THE RIGHT MAIN BRONCHIAL MEMBRANOUS PORTION. IN ADDITION, CT SCAN SHOWED THAT THE PREJET OF THE SUTURE AREA APPEARED INTO THE BRONCHIAL LUMEN WITH THE POSTOPERATIVE COURSE, AND IT WAS RECOGNIZED THAT PROTRUSION INTO THE TRACHEA INNER CAVITY BY CT SCAN AT 1 YEAR AND 5 MONTHS AFTER THE OPERATION. AFTER BRONCHOSCOPY, THE PATIENT DEVELOPED PNEUMONIA, SO THE DOCTOR PERFORMED AN ANTIBIOTIC TREATMENT. FURTHERMORE, AS A RESULT OF PATHOLOGICAL EXAMINATION, NO MALIGNANT FINDINGS WERE FOUND, SO THE DOCTOR DIAGNOSED A REACTIVE GRANULOMA TO SUTURE AND PREJET. IN ORDER TO SUPPRESS THE FORMATION OF GRANULOMA, ANTI-ALLERGIC AND STEROID TREATMENT WAS PERFORMED, THE GRANULOMA MARKEDLY DECREASED IN SIZE AFTER A MONTH. IT WAS TRIED TO REMOVE THE GRANULOMA WITH FORCEPS, BUT IT WAS DIFFICULT TO REMOVE, SO THE DOCTOR DECIDED THAT IT WAS NOT TO SURGICALLY REMOVE THE GRANULOMA AND TO CONTINUE CONSERVATIVE TREATMENT WITH STEROIDS. NO RELAPSES OF BLOODY SPUTUM OR WHEEZING HAVE BEEN RECOGNIZED. <CONSIDERATION> IN THIS CASE, IT IS CONSIDERED THAT SUTURE FAILURE OCCURRED BECAUSE THE PREJET TRANSFERRED FROM THE CHEST CAVITY TO THE ENDOTRACHEAL. IT IS CONSIDERED THAT ISCHEMIA DUE TO SUTURE AND/OR INFECTION TO THE PREJET CAUSED NECROSIS OF THE MEMBRANOUS PORTION, SO THE PREJET PIERCED THROUGH THE MEMBRANOUS PORTION OF THE BRONCHUS AND APPEARED IN THE LUMEN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042387 PROLENE SUTURE 30"(75CM) 4-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10705031021549

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention