BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 7991088 · Received October 22, 2018

    Report

    Report Number
    1037905-2018-00493
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    October 11, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT IS BEING CORRECTED FROM 09/27/2018 TO 10/11/2018. INFORMATION REGARDING COMMON DEVICE NAME- SUSPECT MEDICAL DEVICE. COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING DEN170015. 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. THE INSTRUCTIONS FOR USE (IFU) ADDRESS POTENTIAL CLINICAL PROCEDURE RELATED COMPLICATIONS, INCLUDING A CAUTION RELATED TO DISTENTION OF THE STOMACH: "CAUTION: ENSURE GASTROINTESTINAL LUMEN IS NOT DISTENDED BECAUSE HEMOSPRAY ADDS VOLUME DURING PROCEDURE." THE IFU ALSO INCLUDES THE FOLLOWING INFORMATION RELATED TO THE OCCURRENCE OF PERFORATION: [HEMOSPRAY IS] "ALSO CONTRAINDICATED IN PATIENTS WHO HAVE GASTROINTESTINAL FISTULAS, ARE SUSPECTED OF HAVING A GASTROINTESTINAL PERFORATION, OR ARE AT HIGH RISK OF GASTROINTESTINAL PERFORATION DURING ENDOSCOPIC TREATMENT." THE IFU INDICATES THE FOLLOWING POTENTIAL COMPLICATIONS: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTAT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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

    DURING A GASTRIC ENDOSCOPIC MUCOSAL RESECTION (EMR). THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THERE WAS A POSSIBLE PERFORATION RELATED TO HEMOSPRAY AFTER A GASTRIC EMR (ENDOSCOPIC MUCOSAL RESECTION). THE FOLLOWING WAS RECEIVED ON 10/29/2018: THE LOCATION OF THE VENOUS OOZING WAS IN THE PROXIMAL STOMACH. THE STOMACH HAD SOME DISTENTION TO ALLOW FOR VISUALIZATION. THE POST-POLYPECTOMY SITE WAS COMPLETELY VISUALIZED AFTER THE EMR. PRIOR TO HEMOSPRAY APPLICATION, SNARE TIP DIATHERMY WAS PERFORMED TO ATTEMPT HEMOSTASIS. SEVERAL SPRAYS OF HEMOSPRAY WERE PERFORMED WHICH MADE DIRECT CONTACT WITH THE TARGET BLEEDING SITE. A PERFORATION OCCURRED, AND LAPAROTOMY SURGERY WAS PERFORMED TO TREAT THE PERFORATION. PER THE TREATING PHYSICIAN, "I THINK THE PERFORATION MAY HAVE BEEN CONTRIBUTED BY HEMOSPRAY BUT IMPORTANTLY, OTHER INTRINSIC PATIENT/MUCOSAL FACTORS MAY ALSO BE IN PLAY. THE PERFORATION OCCURRED AFTER EMR WAS COMPLETED, AND UPON APPLICATION OF HEMOSPRAY, BUT THERE MAY HAVE BEEN OTHER FACTORS CONTRIBUTING TO THE PERFORATION (I.E.. WEAK MUCOSAL DEFECT, ETC.). OTHER INTRINSIC PATIENT/MUCOSAL FACTORS MAY ALSO BE IN PLAY." AN UNINTENDED PORTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED A LAPAROTOMY DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED A PERFORATION THAT COULD HAVE BEEN CONTRIBUTED TO BY HEMOSPRAY.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE- COMMON DEVICE NAME: NOT AVAILABLE, REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION: DEN170015. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP EMDR REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A GASTRIC ENDOSCOPIC MUCOSAL RESECTION (EMR). THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THERE WAS A POSSIBLE PERFORATION RELATED TO HEMOSPRAY AFTER A GASTRIC EMR (ENDOSCOPIC MUCOSAL RESECTION). ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME IS IN THE PROCESS OF BEING COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830516 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE, UNKNOWN MAKE OR MODEL| ENDOSCOPE, UNKNOWN MAKE OR MODEL