BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18818267 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02205
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    January 1, 2022
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: THE AMERICAN SURGEON, (2022); 88 (5): 1014¿1015. HTTPS://DOI.ORG/10.1177/00031348211069794.

    Description of Event or Problem · 0

    TITLE: BULLET EMBOLISM INTO THE COMMON ILIAC ARTERY FROM A GUNSHOT WOUND TO THE HEART THIS IS A CASE REPORT OF A 15-YEAR-OLD BOY WHO WAS BROUGHT TO THE TRAUMA BAY BY AMBULANCE FOLLOWING A SHOOTING AT A BLOCK PARTY WITH A SINGLE GUNSHOT WOUND TO THE RIGHT CHEST. ON ARRIVAL, HIS AIRWAY WAS INTACT, HE HAD DYSPNEA WITH NORMAL BREATH SOUNDS BILATERALLY, AND JUGULAR VENOUS DISTENSION WITH NORMAL HEMODYNAMICS. A SINGLE ANTERIOR BALLISTIC WOUND WAS NOTED OVER THE RIGHT CHEST JUST INFERIOR TO THE MIDCLAVICLE, WITH NO EVIDENCE OF PERITONITIS. BEDSIDE ULTRASOUND OF THE HEART REVEALED A LARGE PERICARDIAL EFFUSION CONCERNING FOR CARDIAC INJURY. HE UNDERWENT PLAIN RADIOGRAPHS OF THE CHEST AND PELVIS, WITH A BALLISTIC PROJECTING OVER THE RIGHT MID-ABDOMEN. DUE TO THE CONCERN FOR POLYCOMPARTMENT INJURY AND CONCERN FOR PROGRESSIVE TAMPONADE, THEY ELECTED TO PROCEED WITH EMERGENT PERICARDIAL WINDOW. THEY PERFORMED AN ARTERIOTOMY AND EXTRACTED THE BULLET, THEN PERFORMED FOGARTY CATHETER THROMBECTOMY CLOSED THE ARTERIOTOMY. AS THEY BELIEVED THAT THE BULLET HAD LIKELY EMBOLIZED FROM THE HEART, THEY THEN WANTED TO PERFORM A FULL EXPLORATION OF THE PERICARDIUM AND MEDIASTINUM. THEY PERFORMED A MIDLINE STERNOTOMY AND EXPLORED THE MEDIASTINUM. THEY NOTICED A BALLISTIC WOUND ON THE RIGHT SIDE OF THE PERICARDIUM, AND IN THE SAME TRAJECTORY, AN INJURY TO THE SUPERIOR VENA CAVA ¿ RIGHT ATRIAL (SVC-RA) JUNCTION. IT WAS HEMOSTATIC AT THE TIME OF EXPLORATION, BUT WITH FURTHER INVESTIGATION THERE WAS A FAIR AMOUNT OF BLEEDING THAT OCCURRED FROM THAT SVC-RA INJURY. WITH DIGITAL PRESSURE, THE BLEEDING WAS CONTROLLED AND FIGURE-OF-EIGHT 3-0 PROLENE SUTURES WERE USED TO OBTAIN CONTROL. AT THE SAME TIME, THEY ALSO PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY AND BRONCHOSCOPY WITH NO EVIDENCE OF FURTHER MEDIASTINAL INJURY. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. TRANSTHORACIC AND TRANSESOPHAGEAL AGITATED-SALINE ECHOCARDIOGRAMS SHOWED NO EVIDENCE OF RESIDUAL ATRIAL OR VENTRICULAR SEPTAL DEFECTS. HE HAD A PROLONGED POSTOPERATIVE RECOVERY COMPLICATED BY RIGHT HEMOTHORAX, BUT WAS DISCHARGED TO HOME AFTER A 2-WEEK HOSPITAL STAY. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: 15 YEAR OLD, MALE. -PROLONGED POSTOPERATIVE RECOVERY COMPLICATED BY RIGHT HEMOTHORAX TREATMENT: NOT MENTIONED. IN CONCLUSION, THIS CASE OF PENETRATING RIGHT-SIDED THORACIC TRAUMA POSES A NUMBER OF MANAGEMENT CHALLENGES. FIRST, THERE WAS CLINICAL EVIDENCE OF EARLY CARDIAC TAMPONADE WITH JUGULAR VENOUS DISTENTION AND DYSPNEA. SECOND, THE PRESENCE OF A BALLISTIC PROJECTING OVER THE ABDOMEN RAISED SUSPICION FOR TRANSDIAPHRAGMATIC TRAJECTORY WITH INTRAABDOMINAL PATHOLOGY. BULLET EMBOLISM REPRESENTS A RARE BUT COMPLEX SUBSET OF BALLISTIC PENETRATING TRAUMA, AND THE LACK OF TRAUMATIC FINDINGS IN THE ABDOMEN ON EXPLORATION HIGHLIGHTS THE IMPORTANCE OF RADIOGRAPHIC CORRELATION WITH INTRAOPERATIVE FINDINGS; IN THIS CASE, THE X-RAY FINDINGS OF A BALLISTIC IN THE RIGHT LOWER QUADRANT LED TO THE ILIAC ARTERY EXPLORATION AND THE DISCOVERY OF THE INTRALUMINAL BULLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309815 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Other