BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3024002 · Received March 27, 2013

    Report

    Report Number
    3005099803-2013-02074
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(4) 2013 THAT A PATIENT WAS EXPERIENCING ISSUES THAT MAY BE RELATED TO A RESOLUTION CLIP DEVICE. INFORMATION RECEIVED ON (B)(4) 2013 REVEALED THAT TWO RESOLUTION CLIP DEVICES HAD BEEN PLACED. THESE DEVICES HAD BEEN USED TO TREAT BLEEDING FROM AN ESOPHAGEAL BOTOX PROCEDURE (INTENDED TO RELIEVE SPASMS), PERFORMED IN (B)(6) 2011. THE PATIENT IS A (B)(6) WOMAN WITH A LONG-STANDING HISTORY OF GASTROINTESTINAL ISSUES, INCLUDING GASTROPARESIS THAT GIVES HER VERY FREQUENT NAUSEA AND VOMITING SYMPTOMS, ACCORDING TO DR (B)(6) (HER LONG TERM GI PHYSICIAN). PRIOR TO THE PLACEMENT OF THE RESOLUTION CLIPS THE PATIENT HAD MANY EGD PROCEDURES TO EVALUATE HER GI SYMPTOMS (NAUSEA AND VOMITING). THE PATIENT UNDERWENT SURGERY TO REMOVE AN OVARY IN (B)(6) 2012. CURRENTLY, DUE TO HER MULTIPLE HEALTH ISSUES, THE PATIENT'S MEDICAL AND LEGAL DECISIONS ARE MADE BY HER MOTHER (THE INITIAL COMPLAINANT). ON (B)(6) 2012, THE PATIENT HAD AN MRI, PERFORMED AT (B)(6). THE PATIENT EXPERIENCED PAIN, A "BURNING FEELING" AND FELT SICK FOLLOWING THE MRI. SHE ALSO HAD DIFFICULTY EATING AND KEEPING FOOD DOWN. IN LATE (B)(6) 2012 THE PATIENT VOMITED ENOUGH THAT SHE WAS HOSPITALIZED THROUGH (B)(6) 2012. ENDOSCOPY REVEALED THAT THE TWO RESOLUTION CLIPS WERE STILL IN PLACE. IN EARLY 2013, IN ADVANCE OF A BRAIN MRI TO FACILITATE DIAGNOSIS OF THE PATIENT'S NAUSEA, BOSTON SCIENTIFIC WAS CONTACTED TO DETERMINE THE PROPER SETTINGS FOR USE OF MRI IN PATIENTS WITH RESOLUTION CLIP DEVICES. INSTRUCTIONS WERE SENT TO THE FACILITY, AND IT WAS CONFIRMED THAT THE PROPER SETTINGS WERE USED DURING THE PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE MRI ON (B)(6) 2013, THE PATIENT IMMEDIATELY EXPERIENCED PAIN IN HER ABDOMEN. AS THE MRI PROCEEDED SHE HAD INCREASING PAIN. THE PATIENT VOMITED AFTER EXITING THE MACHINE, AND VOMITED THREE MORE TIMES AFTER LEAVING FACILITY, FOLLOWED BY DRY HEAVES. THE PATIENT WAS LATER BROUGHT TO (B)(6) ER AND WAS TREATED WITH IV FLUIDS, ZOFRAN, BENADRYL, VALIUM, PROTONIX AND DILAUDID. SINCE THIS MRI, THE PATIENT HAS CONTINUED TO EXPERIENCE PAIN, NAUSEA AND VOMITING. THE PATIENT IS BEING TREATED WITH PHENERGAN AND IM VALIUM FOR MUSCLE SPASMS. FOLLOW UP WITH DR (B)(6) CONFIRMED THAT THE PATIENT HAS A HISTORY OF GI ISSUES WHICH PRECEDED THE PLACEMENT OF THE RESOLUTION CLIP DEVICES. HE STATED THAT "BASED UPON HER GI MEDICAL HISTORY, I DO NOT THINK THE RES CLIPS ARE RELATED AT ALL TO THE SYMPTOMS DURING AND FOLLOWING THE MRI". BOSTON SCIENTIFIC HAS RECEIVED NO OTHER COMPLAINTS FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126770 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER UNK177

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention