BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRLNE BLU 2X30IN 7-0 D/A BV175-6 MP

    MDR report key: 12269639 · Received August 3, 2021

    Report

    Report Number
    2210968-2021-06957
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 27, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031045972
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 09/03/2021. ADDITIONAL H6 HEALTH EFFECT - CLINICAL CODES: E0505. ADDITIONAL INFORMATION: A2, A3, A4, B7, D9, H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH MCQ759, M873335 AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H6 COMPONENT CODE: G07002 ¿ REPORTED CONDITION NOT CONFIRMED ( REPRESENTATIVE SAMPLES). ADDITIONAL H-3 SUMMARY: EIGHT PACKETS OF PRODUCT CODE M8733 WERE RETURNED FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE EIGHT PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO DAMAGED OR BREAKAGE SUTURES AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING AN INSTRON AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? 60YR MALE, 50.4 KG, BMI 19.1. IS IT A DATE OF INDEX SURGICAL PROCEDURE (B)(6) 2021? YES. ON WHAT TISSUE, TYPE OF ANASTOMOSIS WAS THE PROLENE SUTURE USED? VEIN. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? NORMAL HOW MANY SUTURES USED AND BROKE POST-OP ON THIS ONE PATIENT? ONE WAS THE SUTURE BREAKAGE POST-OP OCCURRED AT THE SAME DAY OF INDEX SURGERY (B)(6) 2021? YES. HOW WAS THE SUTURE PLACED, INTERRUPTED OR CONTINUOUS? INTERRUPTED. HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? SQUARE KNOT. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE OR DURING THE SUTURE PLACEMENT? NO. HOW WAS THE POST-OP SUTURE BREAKAGE DIAGNOSED? VISUALIZED HEMATOMA IN POST-OP WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURE BREAKAGE POST-OP AND ANASTOMOSIS FAILURE? NO. WHAT WAS USED FOR RE-SUTURING OF ANASTOMOSIS?- 7-0 PROLENE WERE THERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE POST-OP EVENT? PLEASE DESCRIBE. OTHER THAN HAVING TO BE BROUGHT BACK TO THE O.R., NO. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? - SURGEON STATE THAT THE SUTURE BROKE IN MULTIPLE PLACES AND BELIEVES THE SUTURE WAS OF A BAD LOT. OTHER RELEVANT PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS?- NONE WHAT IS THE PATIENT CURRENT STATUS AFTER SUTURE REPLACEMENT PROCEDURE? GOOD, NO FURTHER ISSUES. 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 Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO RECEIVE A DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT ATTEMPTS ARE BEING MADE TO CLARIFY 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. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? IS IT A DATE OF INDEX SURGICAL PROCEDURE (B)(6) 2021? ON WHAT TISSUE, TYPE OF ANASTOMOSIS WAS THE PROLENE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? HOW MANY SUTURES USED AND BROKE POST-OP ON THIS ONE PATIENT? WAS THE SUTURE BREAKAGE POST-OP OCCURRED AT THE SAME DAY OF INDEX SURGERY (B)(6) 2021? HOW WAS THE SUTURE PLACED, INTERRUPTED OR CONTINUOUS? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE OR DURING THE SUTURE PLACEMENT? HOW WAS THE POST-OP SUTURE BREAKAGE DIAGNOSED? WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURE BREAKAGE POST-OP AND ANASTOMOSIS FAILURE? WHAT WAS USED FOR RE-SUTURING OF ANASTOMOSIS? WERE THERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THE POST-OP EVENT? PLEASE DESCRIBE. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? OTHER RELEVANT PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS THE PATIENT CURRENT STATUS AFTER SUTURE REPLACEMENT PROCEDURE? WILL PRODUCT BE RETURNED? IF YES, PLEASE PROVIDE RETURN DATE, TRACKING INFORMATION? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AV FISTULA SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR ANASTOMOSIS. WHEN THE PATIENT WAS ALREADY IN THE POST-OP UNIT AND PATIENT¿S BLOOD PRESSURE WAS RAISED BACK TO NORMAL LEVEL THE SUTURE SEEMED TO COME APART AND THE ANASTOMOSIS HAD TO BE REVISED. THE PATIENT HAD TO BE RUSHED BACK TO THE OR TO CORRECT THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165843 PRLNE BLU 2X30IN 7-0 D/A BV175-6 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. M8733 MCQ759 10705031045972

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention