FDA Adverse Event Injury Summary report: N

GELFOAM STERILE POWDER

MDR report key: 484838 · Received September 19, 2003

Report

Report Number
1810189-2003-00005
Event Type
Injury
Date Received
September 19, 2003
Date of Event
July 24, 2003
Report Date
September 19, 2003
Manufacturer
PHARMACIA & UPJOHN, KALAMAZOO
Product Code
LMF
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM BAXTER HEALTHCARE CORP. THIS IS A PT DIAGNOSED WITH L-4-5 HERNIATION WITH RADICULOPATHY (AFTER A CAR ACCIDENT) WHO UNDER WENT L4-L5 LEFT HEMILAMINOTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY, MICROSURGICAL DISKECTOMY IN 2003. THE SURGERY WAS DESCRIBED AS MINIMALLY INVASIVE. IT WAS NOTED IN THE OPERATIVE REPORT THAT UPON THE INITIAL EXPOSURE, SOME CEREBROSPINAL FLUID (CSF) WAS SEEN PERCOLATING OUT FROM UNDER THE LIGAMENTUM FLAVUM AND IT WAS APPARENT THAT THE INITIAL ENTRY OF THE FINDER NEEDLE MUST HAVE PENETRATED THE DURA AND CAUSED A SMALL HOLE. THIS AREA WAS PACKED WITH GELFOAM. A ROOT RETRACTOR WAS USED TO RETRACT THE NERVE ROOT MEDIALLY. EPIDURAL VEINS WERE SEEN TO BE ENGORGED FROM THE PRESSURE FROM THE DISK AND THESE WERE COAGULATED. THE LARGE DISK HERNAITION WAS SEEN AND THE ANNULUS WAS INCISED. DISK MATERIAL WAS REMOVED WITH PITUITARY FORCEPS. THE ENDPLATES WERE SCRAPED OFF WITH CURETS AND DISK MATERIAL WAS THOROUGHLY REMOVED WITH PITUITARY RONGEURS. HEMOSTASIS WAS ACHIEVED WITH GELFOAM SPONGE AND GEL POWDER AND THE AREA WAS SEALED WITH HEMASEEL 5 ML. THE PT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE RN NOTED THAT PT'S BP WAS SLOWLY DECREASING (TREATED WITH SALINE BOLUS) AND PT HAD NUMBNESS FROM FOOT TO MIDTHIGH. THE SYMPTOMS PERSISTED AND WORSENED. POST-OPERATIVE DAY 1, THE PT COMPLAINED OF NUMBNESS AND TINGLING PRESENT FROM LEFT HIP DOWN TO LEFT FOOT WITH SOLE VERY SENSITIVE TO TOUCH. PERINEAL AREA WAS ALSO NUMB TO TOUCH BUT THEY WERE ABLE TO URINATE AT THIS TIME. THE PT WAS UNABLE TO DO ABDUCTION ON LEFT LEG AND DORSIFLEX/PLANTAR FLEX LEFT FOOT. THEY UNDERWENT AN MRI, WHICH REVEALED 2.0 X 0.8 CM FLUID COLLECTION SUGGESTING CSF AND BLOOD WITH COMPRESSION OF THECAL SAC. THE SURGEON NOTED WORSENING RADICULOPATHY WITH EXTENSIVE SENSORY LOSS TO PERINEUM. SURGEON NOTED COMPRESSIVE EPIDURAL MASS LESION NOT HEMATOMA, BUT NOT SAME SIGNAL FOR CSF. HE SUPSECTED THAT IT WAS HEMASEEL APPLIED IN OPERATING ROOM WHICH EXPANDED. AT 15:50, THE PT WAS RETURNED TO SURGERY FOR THE REOPENING AND EXPLORATION OF LUMBAR WOUND. ROPENING OF THE INCISION AND THE FASCIA DISCLOSED WHAT APPEARED TO BE A LARGE BALL OF HEMASEEL. THIS WAS REMOVED AS A SOLID PIECE. DEBRIS AND ADD'L HEMASEEL WERE CLEANED OFF THE DURA ADN THE NERVE ROOT AND THIS AREA WAS THOROUGHLY IRRIGATED. GELFOAM POWDER WITH THROMBIN 5,000 UNITS X 2 WAS THEN APPLIED AND LEFT FOR SEVERAL MINUTES FOR SEALANT AND FOR HEMOSTASIS. IT WAS VIGOROUSLY IRRIGATED. HEMASEEL (DOCUMENTED AS 5 ML) WAS THEN APPLIED DIRECTLY TO THE DURA SURFACE, ONLY A THIN LAYER WAS PLACED ON THE DURA. IT WAS NOTED THAT NACL WITH BACITRACIN 50,000 UNITS IRRIGATION WERE USED DURING THIS PROCEDURE. HOWEVER, IT WAS ALSO DOCUMENTED IN THE PT'S CHART THAT THE MASS APPEARED AS AN EXPANDED GELFOAM RESIDUE THAT WAS UNDISSOLVED. SURGEON USED COPIOUS IRRIGATION AND SUCTIONED THE RESIDUAL MATERIAL. NO PATHOLOGY WAS PERFORMED BECAUSE THE REMOVED MATERIAL WAS DISCARDED. THE PT WAS TRANSFERRED TO PACU IN STABLE CONDITION. THE NEXT DAY, THE PT WAS IMPROVING NEUROLOGICALLY. TWO DAYS LATER, THE PT WAS CONTINUING PHYSICAL THERAPY WAS ORDERED. THE PT COMPLAINED OF NUMBNESS EXTENDING ACROSS PELVIS. THE NEUROLOGY EXAM UNCHANGED. THE FOLLOWING DAY THE PT COMPLAINED OF NUMBNESS AND TINGLING IN LOWER LEFT EXTREMITIES. MRI REVEALED MINOR INCREASE IN FLUID COLLECTION IN POST ASPECTS OF LEFT SIDE OF L4 LAMINECTOMY. THE PT CONTINUED TO HAVE NEURO DEFICIT. THE FOLLOWING DAY, THE SURGEON DOCUMENTED URINARY DIFFICULTY. NO NEUROLOGIC CHANGE. UROLOGIST CALLED TO CONSULT. THE IMPRESSION OF THE CONSULTATION WAS THAT OF POSSIBLE CAUDA EQUINA SYNDROME AND SECONDARY DETRUSOR SPHINCTER DYSSYNERGIA. ALSO, POSSIBLE UTI SECONDARY TO URINARY CATHETER POST SURGERY. THE FOLLOWING DAY, THE PT'S CONDITION IMPROVED WITH INCREASED ACTIVITY WITH PHYSICAL THERAPY. THE PT'S MAIN ISSUES AT THIS TIME ARE CONSTIPATION, ANXIETY AND DEPRESSION. TWO DAYS LATER, THE PT WAS DISCHARGED AFTER SOCIAL WORKER'S SUPPORT ADDRESSING FAMILY ISSUES AND HEALTH PROBLEMS. NINE DAYS LATER, THE PT HAD NO FURTHER PROBLEM WITH BOWEL OR BLADDER. THEIR LEG STRNGTH WAS MEASURED AT 4 TO 5. THE RECENT MRI REVEALED INFLAMMATION NOT INCONSISTENT WITH THEIR LAMINECTOMY. THE HOSP CONDUCTED AN INVESTIGATION OF THE EVENT. THE STAFF THAT WAS PRESENT AT THE FIRST AND SECOND SURGERY WERE INTERVIEWED. ONE OF THE SCRUB TECHS RECALLS THAT THE "BALL OF GLUE" IN QUESTION APPEARED TO BE "WADDED UP GELFOAM PAD" WHICH WAS SUCTIONED FROM THE PT AND DISCARDED WITH THE SUCTION CANISTER. HOWEVER, THE SURGEON ASSESSED THAT HE MIGHT HAVE OVERUSED HEMASEEL APR AND IT IS POSSIBLE THAT THE "BALL OF GLUE" WAS HEMASEEL THAT WAS PUSHING AGAINST THE SPINAL COLUMN. HIS THEORY IS THAT THE GLUE WAS DISLODGED AND ROLLED OVER AND COMPRESSED THE SPINE ONCE THE PT BECAME MOBILE AND BEGAN TO USE THEIR MUSCLES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GELFOAM STERILE POWDER GELATIN LMF PHARMACIA & UPJOHN, KALAMAZOO NA UNK

Patients

Seq Age Sex Outcome Treatment
1 43 YR Hospitalization| R