Description of Event or Problem · 1
ON OCTOBER 19, 1993 AN INCIDENT OCCURRED INVOLVING A 5 FR PINNACLE INTRODUCER SHEATH AND A GLIDECATH WHILE PERFORMING A CAROTID ANGIOGRAM. A THREE VESSEL STUDY ENTAILED FAILED ATTEMPTS WITH A DIAGNOSTIC CATHETER WITH SUBSEQUENT USE OF THE GLIDECATH TO COMPLETE THE PROCEDURE. A TIGHT BUT NON-RESISTANT FIT BEETWEEN THE GLIDECATH AND PINNACLE SHEATH WAS NOTED DURING PROCEDURE. THE PHYSICIAN STATED THE CASE WAS NOT A DIFFICULT STUDY AND HE ENCOUNTERED NO OVERT COMPLICATIONS. POST PROCEDURE THE PT COMPLAINED OF A COLD RIGHT FOOT, INDICATING THROMBUS. THE PT WAS ADMITTED AND PLACED ON A HEPARIN DRIP OVERNIGHT. UPON DISACHARGE THE PT WAS ASYMPTOMATIC AND REMAINS ASYMPTOMAAATIC TODATE. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS AND THE PROCEDURE REQUIRED 34 MINUTES TO COMPLETE. THIS PHYSICIAN FEELS THE TIGHT FIT BETWEEN THE GLIDECATH AND SHEAATH MAY HAVE CONTRIBUTED TO THIS EVENT. IT IS UNKNOWN IF THE PT'S THROMBUS WAS DUE TO AN INHERENT ANTICIPATED COMPLICATION OF ANGIOGRAM OR OTHER CONTRIBUTING FACTORS. THE PRODUCTS WERE DESTROYED AND ARE NOT AVAILABLE FOR EVALUATION.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.