BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR PRO

    MDR report key: 12960973 · Received December 8, 2021

    Report

    Report Number
    3005099803-2021-07758
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE OF INCIDENT WAS APPROXIMATED TO (B)(6) 2021 TO (B)(6) 2021 AS NO EVENT DATE WAS REPORTED. THE UPN AND LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED IN THE LITERATURE; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. REPORT SOURCE: LITERATURE SOURCE: C. SOMMARIVA, A. LAURO, N. PAGANO, S. VACCAR, V. D'ANDREA, I. R. MARINO, M. CERVELLERA, V. TONINI (JUNE 13, 2019). SUBCAPSULAR HEPATIC HEMATOMA POST-ERCP. DIGESTIVE DISEASES AND SCIENCES (2019) 64:2114 - 2119; HTTPS://DOI.ORG/10.1007/S10620-019-05679-3 (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN EXTRACTOR PRO RETRIEVAL BALLOON THROUGH THE ARTICLE SUBCAPSULAR HEPATIC HEMATOMA POST ERCP WRITTEN BY C. SOMMARIVA, ET AL. ACCORDING TO THE LITERATURE, AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED FOR STONE EXTRACTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. TWO DAYS AFTER THE ERCP PROCEDURE, THE PATIENT REPORTED THE DISCHARGE OF SEMIFLUID DARK FECES WITHOUT ABDOMINAL PAIN. DIGITAL RECTAL EXAMINATION WAS NEGATIVE; SINCE A CBC SHOWED ACUTE SEVERE ANEMIA (HGB 8.3 G/DL), 1 UNIT OF BLOOD WAS TRANSFUSED EVEN THOUGH THE PATIENT WAS HEMODYNAMICALLY STABLE. IN ORDER TO EXCLUDE HEMOBILIA, AN EGD WAS PERFORMED, WITH NO SIGNS OF ACTIVE OR RECENT BLEEDING IN THE FOREGUT. A REPEAT ABDOMINAL CT SCAN SHOWED A LARGE 8 X 12 CM SUBCAPSULAR AND INTRAPARENCHYMAL HEMATOMA AFFECTING THE RIGHT LIVER SEGMENTS (VI/VII/VIII) WITHOUT ACTIVE BLEEDING. PNEUMOBILIA WAS REPORTED, PARTICULARLY IN THE LEFT LOBE. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY SURGERY UNIT, WHERE HE WAS TREATED CONSERVATIVELY DUE TO CLINICAL STABILITY (SUBSEQUENT HGB 8.3 G/DL WITHOUT ADDITIONAL BLOOD TRANSFUSIONS). IN THE FOLLOWING DAYS, HIS CLINICAL CONDITION IMPROVED ACCOMPANIED WITH INCREASING HGB (10.4 G/DL). ABDOMINAL ULTRASOUND WITH SONOVUE CONTRAST DOCUMENTED A STABLE HEMATOMA. THE PATIENT WAS DISCHARGED IN GOOD CLINICAL CONDITION AFTER 7 DAYS OF ANTIBIOTIC THERAPY. A CT SCAN PERFORMED AFTER 1 WEEK FROM DISCHARGE SHOWED A STABLE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862687 EXTRACTOR PRO CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention