BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINPOINT ICG PAQ

    MDR report key: 7700315 · Received July 18, 2018

    Report

    Report Number
    3012345110-2018-00003
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 19, 2018
    Report Date
    February 7, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    02085870100617
    PMA / PMN Number
    K150956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: ICG ANAPHYLACTIC. PATIENT WHO WAS GOING TO HAVE FLORO IAMGING FOR GALL BLADER SURGERY. PATIENT WAS GIVIN 0.5 MG OF ICG 30 MIN BEFORE SURGERY. PATIENT WAS TAKEN TO THE OR, APROX 40 MINUTE AFTER ICG INJECTION PATIENT STARTED SHOWING SYMPTOMS OF ANAPHYLACTIC RESPONSE. NOW THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT ON A RESPIRATOR. PROBABLE ROOT CAUSE/S: CAUSE OF ISSUE LIKELY DUE TO ANAPHYLACTIC REACTION TO ICG. WHILE THE TIMING OF THE REPORTED SYMPTOMS WAS CONSIDERED UNUSUAL BY OEM QP PHARMACOVIGILANCE, THE SYMPTOMS THEMSELVES (RASH, SWELLING) ARE CONSISTENT WITH AN ANAPHYLACTIC REACTION. ICG DOSAGE AND ADMINISTRATION TIMING WERE CONFIRMED AND OEM DID NOT ANY ADDITIONAL FEEDBACK REGARDING INCIDENT. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION DUE TO BEING CONSUMED DURING PROCEDURE. HOWEVER, REPORTED FAILURE MODE WAS CONFIRMED BASED ON REVIEW OF PATIENT MEDICAL INFORMATION BY OEM. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN ANAPHYLACTIC RESPONSE FOLLOWING ICG INJECTION. ADDITIONAL INFORMATION CONFIRMED PATIENT WAS LATER DISCHARGED HOME.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER OF THE ICG HAS BEEN NOTIFIED OF THIS EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE, IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ANAPHYLACTIC RESPONSE FOLLOWING ICG INJECTION. ADDITIONAL INFORMATION CONFIRMED PATIENT WAS LATER DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541465 PINPOINT ICG PAQ LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 18056 02085870100617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other