BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18634281 · Received February 2, 2024

    Report

    Report Number
    1037905-2024-00062
    Event Type
    Injury
    Date Received
    February 2, 2024
    Report Date
    February 2, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K200972. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED. THE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS, "LIKE OTHER MODALITIES, HEMOSPRAY MAY NOT BE EFFECTIVE FOR ALL TYPES OF BLEEDS. GASTROINTESTINAL BLEEDING MAY EXACERBATE EXISTING COMORBIDITIES, INCREASING THE POTENTIAL FOR ADVERSE EVENTS INCLUDING PATIENT MORTALITY." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2023. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "PATIENT WAS A 54-YEAR-OLD WOMAN WITH PWS AND AN ASSOCIATED HISTORY OF PANCYTOPENIA, AVMS, HEMANGIOMAS, LYMPHANGIOMAS, IRON-DEFICIENCY ANEMIA, HEMATURIA, AND DEEP VENOUS THROMBOSES. SHE PRESENTED TO THE HOSPITAL AFTER SEVEN EPISODES OF PAINLESS HEMATOCHEZIA OVER 1 DAY AND DENIED HEMATEMESIS OR RECENT USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS/ANTICOAGULATION.. COLONOSCOPY REVEALED RECTOSIGMOID THICKENING WITH MULTIPLE ABNORMAL SUBMUCOSAL LESIONS, EXTENDING 35 CM FROM THE ANUS WITH DILATED SUPERFICIAL SUBMUCOSAL VESSELS AND ACTIVE BLEEDING. ENDOSCOPIC HEMOCLIPS AND HEMOSTATIC POWDER (HEMOSPRAY) WERE APPLIED TO THE BLEEDING VESSELS. DUE TO ONGOING HEMATOCHEZIA, THE PATIENT UNDERWENT PELVIC AND MESENTERIC ANGIOGRAPHY, WHICH DID NOT IDENTIFY THE SOURCE OF THE ACTIVE BLEED. THE PATIENT¿S HEMOGLOBIN REACHED A NADIR OF 5.0 G/DL, AND SHE WAS RECOMMENDED FOR SURGICAL INTERVENTION TO CONTROL THE BLEEDING. THE PATIENT SUBSEQUENTLY UNDERWENT AN OPEN LOW ANTERIOR RESECTION WITH ULTRA-LOW COLOANAL ANASTOMOSIS AND DIVERTING LOOP ILEOSTOMY. THE COLON AND RECTUM WERE REMOVED, AND A MUCOSECTOMY OF THE ANAL CANAL WAS PERFORMED. FINAL PATHOLOGY CONFIRMED A REMARKABLE BURDEN OF AVMS IN THE RECTOSIGMOID COLON, INVOLVING THE ENTIRE CIRCUMFERENCE OF THE RECTUM. SURGERY WAS WITHOUT COMPLICATION.. SHE HAD APPROPRIATE OSTOMY OUTPUT BY POSTOPERATIVE DAY 1 AND WAS DISCHARGED ON POSTOPERATIVE DAY 8. SHE WAS DOING WELL AT HER 2-MONTH POSTOPERATIVE VISIT." THIS MDR IS BEING SENT TO CAPTURE THE HEMATOCHEZIA AFTER USE OF HEMOSPRAY. THE HEMATOCHEZIA WAS OCCURRING PRIOR TO USE OF THE HEMOSPRAY, AND AFTER HEMOSPRAY WAS USED BUT HEMOSTASIS NOT ACHIEVED. SURGICAL INTERVENTION WAS PERFORMED TO CONTROL BLEEDING. WORLD JOURNAL OF COLORECTAL SURGERY 11(1):P 10-13, JAN¿MAR 2022. DOI: 10.4103/WJCS.WJCS_12_22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373302 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention ENDOSCOPE, UNKNOWN MAKE OR MODEL.