BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRLNE BLU 30IN 6-0 D/A BV-1 EP

    MDR report key: 19215625 · Received April 30, 2024

    Report

    Report Number
    2210968-2024-04995
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031208308
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. CORRECTED INFORMATION: H6 HEALTH EFFECT CLINICAL CODES. ADDITIONAL INFORMATION: A2, A3, A4, B3, H4, H6 TYPE OF INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HERE ARE THE ANSWERS FROM THE SURGEON DID 3 SUTURE BREAK POST-OP? IF NO, PLEASE EXPLAIN. UNDER OPERATION TWICE, CHANGED TO NEW, WHEN REOPERATED FOUND IT BRAKED. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE; 77 YEARS , MALE. 64 KG. DATE AND NAME OF INDEX SURGICAL PROCEDURE? LEFTA SIDE CAROTID TROMBEENDARECTOMY. PAF 21. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? AMAUROSIS FUGAX AND MINOR STROKE. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? OPEN. ON WHAT TISSUE WAS THE SUTURE USED? CAROTID ARTERY. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? NORMAL EFTER TROMBUS AND CALIFICATION WAS REMOVED. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? MULTIPLE KNOTS. WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? HANDS , WHEN DISPUTED - NEEDLE HOLDER. HOW MANY DAYS POST-OP WAS THE SUTURE BREAKAGE NOTED? SAME DAY AFTER 3.5 HOURS. HOW WAS IT DETERMINED THAT THE SUTURE BROKE POST-OP? VISUALY , DURING REOPERATION. DID THE WOUND DEHIS? IF YES, WHAT TISSUE DEHISCED? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. USED ANOTHER SUTURE- FROM THE OTHER BOX. WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? CAN NOT ANSWER. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? DURING 3 TIMES SUTURE WAS BROKEN. USED NEW TO RESUTURATING AND THAT SUTURE WAS BROKEN AFTER 3.5 HOUR. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 15.04.2024. LARGE HAEMATOMA IN OPEARTED PLACE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? ANTOCOAGULANTS - CLOPIDOGREL. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WEAK SUTURE. WHAT IS THE PATIENT'S CURRENT STATUS? HOARSENESS - AFTER 4 WEEKS POSTOPERATIVE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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 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. DID 3 SUTURE BREAK POST-OP? IF NO, PLEASE EXPLAIN. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? 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.)? WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? HOW MANY DAYS POST-OP WAS THE SUTURE BREAKAGE NOTED? HOW WAS IT DETERMINED THAT THE SUTURE BROKE POST-OP? DID THE WOUND DEHIS? IF YES, WHAT TISSUE DEHISCED? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 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? WILL THE PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. NOTE: RELATED EVENTS REPORTED VIA 2210968-2024-04993, 2210968-2024-04994, AND (B)(6).

    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: D9, H3, H6. ADDITIONAL H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM. ADDITIONAL H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, ONE OPEN BOX WITH TWENTY UNOPENED SAMPLES PERTAIN TO THE PRODUCT CODE EP8709H. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, AND NO DEFECTS WERE FOUND ON THE PACKAGES. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO ISSUES RELATED TO BREAKAGE SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. ALSO, A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE BROKE. THIS RESULTED IN A REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134361 PRLNE BLU 30IN 6-0 D/A BV-1 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. THBBBX 10705031208308

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention