BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSOMAT AND SPRAY SET

    MDR report key: 2635142 · Received June 29, 2012

    Report

    Report Number
    2954761-2012-00024
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    June 1, 1990
    Report Date
    June 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    FMF
    PMA / PMN Number
    K981089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS AN ADVERSE EVENT REPORTED IN AN ARTICLE WRITTEN BY LANGE ETAL PUBLISHED IN 1990 WHICH CLEARLY DESCRIBES THE USE OF THE GAS REGULATOR (TISSOMAT) IN COMBINATION WITH A FOUR LUMEN SPRAY APPLICATION CATHETER TO DELIVER TISSEEL FIBRIN SEALANT THROUGH AN ABNORMAL CHANNEL (FISTULA). THIS FOUR LUMEN SPRAY APPLICATION CATHETER WAS SUBSEQUENTLY REMOVED FROM THE GLOBAL MARKET IN 1990. THE USE OF THIS NARROW DIAMETER, LONG CATHETER TO DELIVER FIBRIN SEALANT IN CONJUNCTION WITH COMPRESSED GAS LEAD TO PERSISTENT PNEUMOPERITONEUM (GAS ENTRAPMENT) WHICH REQUIRED DEFLATION VIA PERCUTANEOUS PUNCTURE. THE USE OF THE TISSOMAT WITH THE CURRENTLY APPROVED SPRAY SET DOES NOT CARRY THE SAME RISK. THE SPRAY SET INSTRUCTIONS FOR USE CLEARLY STATE TO KEEP BETWEEN THE SPRAY HEAD TIP 10 - 20CM AWAY FROM THE TISSUE AND THE LENGTH OF THE SPRAY HEAD DOES NOT ALLOW FOR INSERTION INTO A NARROW CHANNEL OR CAVITY. THE SPRAY CATHETER WHICH ALLOWED APPLICATION INTO A VERY NARROW ORIFICE WAS THE CAUSE OF THIS EVENT. THE TISSOMAT GAS REGULATOR WHILE A CONTRIBUTING FACTOR IS NOT INDICATED FOR USE WITH ANY OTHER APPLICATORS OTHER THAN THE SPRAY SETS WHICH DO NOT ALLOW FOR APPLICATION IN SMALL CAVITIES NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    FROM LITERATURE: V. LANGE, G. MEYER, H. WENK, AND F.W. SCHILDBERG. FISTULOSCOPY ? AN ADJUVANT TECHNIQUE FOR SEALING GASTROINTESTINAL FISTULAE (1990). SURGICAL ENDOSCOPY. 1990; 4: 212-216 PATIENT (B)(6), A (B)(6) MAN WITH NECROTIZING PANCREATITIS, PERFORATION OF THE DUODENAL BULB AND ABSCESS FORMATION, UNDERWENT A BILLROTH II GASTRECTOMY (ROUX-EN Y ANASTOMOSIS), CHOLECYSTECTOMY, AND DEBRIDEMENT OF PANCREATIC NECROSIS. THE POST-OPERATIVE COURSE WAS UNEVENTFUL UNTIL THE 6TH DAY WHEN PURULENT MATERIAL DRAINED FROM THE ROBINSON CATHETER PLACED BETWEEN THE GASTROJEJUNOSTOMY AND THE PANCREAS. A FISTULOGRAM DEMONSTRATED A BRANCHED FISTULA AROUND THE PANCREAS WITH A CONNECTION TO THE GASTRIC ANASTOMOSIS AND TO THE LEFT COLON. FIBRIN SEALING OF THE SMALL DEFECT IN THE GASTRIC ANASTOMOSIS DID NOT STOP THE PURULENT OUTFLOW. THEREFORE, A SECOND ATTEMPT WAS CARRIED OUT AFTER A TOTAL OF 25 DAYS CONSERVATIVE TREATMENT. THE GASTRIC LEAKAGE WAS AGAIN OCCLUDED BY FIBRIN. THE FISTULA OPENING IN THE COLON COULD NOT BE EXPOSED, ALTHOUGH PUS WAS VISIBLE IN THE BOWEL LUMEN. UNDER FLUOROSCOPIC CONTROL, A BRONCHOSCOPE WAS INTRODUCED INTO THE FISTULA AND POSITIONED AS CLOSE AS POSSIBLE TO THE COLON, WHERE A COLONOSCOPE WAS HELD IN FRONT OF THE SUSPECTED OPENING FISTULA. EIGHTY MILLIGRAMS OF GENTAMICIN WAS INSTILLED VIA THE BRONCHOSCOPE, AND WHEN WITHDRAWING THE INSTRUMENT 10 ML FIBRIN GLUE WAS SPRAYED INTO THE FISTULA. THE REMAINING FISTULA TRACTS WERE FILLED WITH 20 ML PROLAMIN INTRODUCED THROUGH THE OPENING IN THE SKIN. IN THE FOLLOWING DAYS, THERE WAS NO DRAINAGE FROM THE FISTULA AND THE PATIENT REMAINED AFEBRILE. A PERSISTING PNEUMOPERITONEUM DEVELOPED AND WAS RELATED TO THE GAS-JET APPLICATION BY THE TISSOMAT USED TO OBTAIN A BETTER VIEW DURING FISTULOSCOPY. THIS NECESSITATED DEFLATION OF THE ABDOMEN BY PERCUTANEOUS PUNCTURE. ORAL NUTRITION WAS ALLOWED ON THE 4TH DAY, AND THE PATIENT WAS DISCHARGED, CURED, 1 WEEK LATER. THE PATIENT WAS SYMPTOM-FREE AND COMPLETELY RECOVERED AT THE 3-MONTH FOLLOW-UP. NO ADDITIONAL INFORMATION IS AVAILABLE ON THE CASE AND DUE TO THE AGE OF THE PUBLICATION NO FOLLOW-UP WILL BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSOMAT AND SPRAY SET SYRINGE, PISTON FMF BAXTER HEALTHCARE - VIENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 Other