BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA-G SYSTEM

    MDR report key: 19627573 · Received June 27, 2024

    Report

    Report Number
    3015177732-2024-00003
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 27, 2024
    Manufacturer
    COAPTECH, INC.
    Product Code
    KGC
    UDI-DI
    00850026037043
    PMA / PMN Number
    K183057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT WAS OVERFEEDING OF THE GUIDEWIRE WHICH MAY BE COUPLED WITH INTERFERENCE WITH INTERNAL ANATOMY (I.E., THE OMENTUM), PREVENTING MOVEMENT OF THE GUIDEWIRE TO COMPLETE THE PROCEDURE PRIOR TO SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    THE INITIAL STEPS OF THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE WERE COMPLETED TO ACHIEVE COUPLING BETWEEN THE PIGTAIL GUIDEWIRE (PGW) AND INTERNAL BALLOON CATHETER (IBC). AS THE COUPLED IBC-PGW WAS FED THROUGH THE OROGASTRIC TRACT, THE NASOGASTRIC TUBE (NGT) WAS REMOVED AS THE PRIMARY PROCEDURALIST THOUGHT IT WAS POTENTIALLY INTERFERING WITH THE IBC REMOVAL. ONCE OUTSIDE OF THE MOUTH, THE BALLOON WAS NOT COUPLED WITH THE PGW (I.E., THE PIGTAIL WAS NOT INSIDE THE BALLOON). A GLIDESCOPE WAS USED TO EXAMINE THE ORAL CAVITY AND PHARYNX BUT THE PGW WAS NOT FOUND. THE GUIDEWIRE WAS REMOVED FROM THE ABDOMINAL END, AND THE CLINICAL TEAM CHOSE TO CONTINUE WITH A SECOND KIT. AFTER IBC INSERTION, THE BALLOON WAS NOT VISUALIZED IMMEDIATELY. A NEW NGT WAS INSERTED FOR ADDITIONAL INSUFFLATION, AFTER WHICH THE BALLOON WAS VISUALIZED AGAIN AT 3CM TISSUE DEPTH. AGAIN, THE INITIAL STEPS OF THE PUG PROCEDURE WERE COMPLETED WITHOUT ISSUE, AND THE COUPLED IBC-PGW WAS ADVANCED THROUGH THE OROGASTRIC TRACT; THIS TIME BOTH WERE RETRIEVED THROUGH THE MOUTH. AFTER RETRIEVING ABOUT 15CM OF THE PGW OUT OF THE MOUTH, THE PROCEDURALIST FELT RESISTANCE AND WAS UNABLE TO CONTINUE ADVANCING THE GUIDEWIRE. THE GLIDESCOPE WAS USED TO INSPECT THE ORAL CAVITY AND PHARYNX BUT DID NOT VISUALIZE ANYTHING ABNORMAL. THE PROCEDURALIST ATTEMPTED TO REDUCE THE PGW BY PULLING AT BOTH THE ORAL AND ABDOMINAL ENDS BUT ONLY FELT RESISTANCE. HE WAS ABLE TO ADVANCE THE PGW FURTHER AT THE ABDOMEN BUT COULD NOT PULL MORE FROM THE ORAL END. AT THIS POINT, COAPTECH CLINICAL SUPPORT SUGGESTED TAKING X-RAYS TO HELP DETERMINE THE ISSUE. IMAGING REVEALED AN EXCESSIVE AMOUNT OF LOOPED GUIDEWIRE IN THE ABDOMINAL CAVITY. IT WAS RECOMMENDED THAT THE DOCTOR CONTINUE TO TRY TO REDUCE THE GUIDEWIRE FROM THE ABDOMINAL SIDE, WHICH WAS SUCCESSFUL IN RETRIEVING ABOUT 15CM OF ADDITIONAL WIRE. MORE GUIDEWIRE WAS ABLE TO BE FED OUT OF THE MOUTH AS WELL. ANOTHER X-RAY SHOWED A DECREASE OF GUIDEWIRE IN THE ABDOMINAL CAVITY BUT SOME LOOPING REMAINED. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED BY GI AT THE BEDSIDE, CONCLUDING THAT THE EXCESS GUIDEWIRE WAS EXTRAGASTRIC. THE PATIENT WAS THEN TRANSPORTED TO THE OR TO RECEIVE LAPAROSCOPY BY A SURGEON. FINDINGS SHOWED THE GUIDEWIRE LOOPED WITHIN A SMALL PORTION OF THE OMENTUM. THE OMENTUM WAS DISSECTED, FREEING THE GUIDEWIRE, WHICH HAD NO VISIBLE DAMAGE. THE G-TUBE WAS INSERTED USING THE INTACT GUIDEWIRE AND A PUSH G-TUBE KIT. THE G-TUBE WAS SECURED AT 4CM. NO FURTHER COMPLICATIONS OR CLINICAL EFFECTS RELATED TO THE PUG PROCEDURE WERE REPORTED FOLLOWING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815823 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 001021X 00850026037043

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention GASTROSTOMY TUBE.| TRACHEOSTOMY TUBE.