FDA Adverse Event Injury Summary report: N

THERAPEUTIC BRONCHOSCOPE

MDR report key: 376508 · Received February 12, 2002

Report

Report Number
376508
Event Type
Injury
Date Received
February 12, 2002
Date of Event
January 18, 2002
Report Date
January 29, 2002
Manufacturer
PENTAX PRECISION INSTRUMENT CORPORATION
Product Code
EQN
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT WAS BROUGHT TO THIS FACILITY VIA AMBULANCE FOR EVALUATION OF CHILLS, ACUTE SHORTNESS OF BREATH, NON PRODUCTIVE COUGH, AND INCREASING WEAKNESS. FEVER OF UNKNOWN ORIGIN AND URINARY RETENTION WERE IDENTIFIED BY THE EXAMINING EMERGENCY ROOM PHYSICIAN. THE PT'S MEDICAL HISTORY INCLUDED A RECENT PNEMONECTOMY IN ANOTHER FACILITY. A PULMONARY SPECIALIST, REQUESTED ONE WEEK AFTER THE PT'S ADMISSION BECAUSE OF ABNORMAL CHEST CT SCAN FINDINGS, DETERMINED THAT A CT GUIDED THORACENTESIS WAS NEEDED TO DETERMINE IF THE ABNORMALITY IDENTIFIED IN THE LEFT CHEST AREA REPRESENTED AN INFECTION AND A BRONCHOSCOPY WAS NEEDED TO RULE OUT A BRONCHOPLEURAL FISTULA. EIGHT DAYS AFTER ADMISSION, AFTER PLEURAL FLUID WAS REMOVED DURING THORACENTESIS FOR ANALYSIS, THE PT WAS TRANSPORTED TO THE ENDOSCOPY SUITE FOR THE BRONCHOSCOPY. UNDER TOPICAL AND INTRAVENOUS CONSCIOUS SEDATION, THE BRONCHOSCOPE WAS PASSED THROUGH THE PT'S LEFT NARES. NO OBVIOUS BRONCHOPLEURAL FISTULA WAS IDENTIFIED. THE PT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED BACK TO THEIR ROOM. APPROX ONE HOUR AFTER RETURNING TO ROOM, AN ICE PACK WAS APPLIED WHEN BLEEDING FROM THE PT'S LEFT NOSTRIL BEGAN. THE BLEEDING CONTINUED THROUGHOUT THE AFTERNOON AND WHEN THE BLEEDING CONTINUED DESPITE PACKING, OTOLARYNGOLOGY CONSULTATION WAS REQUESTED. CLOTS FROM THE PT'S LEFT NARES AND A LARGE CLOT NOTED IN THE NASOPHARYNX EMANATING INTO THE OROPHARYNX BEHIND THE UVULA WERE REMOVED. AFTER REMOVAL OF THE OROPHARYNGEAL CLOT, IT WAS IDENTIFIED THAT THIS WAS A BRISK POSTERIOR BLEED. AFTER AN EPISTAT WAS PLACED IN THE PT'S LEFT NOSTRIL WITH 4CC OF WATER IN THE ANTERIOR BALLOON AND 3CC OF WATER IN THE POSTERIOR BALLOON, HEMOSTASIS WAS ACHIEVED. THE PT WAS TRANSFERRED THE FOLLOWING DAY TO ANOTHER HOSPITAL FOR EBMOLIZATION OF THE SPHENOPALATINE BRANCHES OF THE CAROTID ARTERY AND INSPECTION OF THE ETHMOID ARTERY FEEDING THE AREA BY AN INTERVENTIONAL RADIOLOGIST. PT WAS THEN TRANSFERRED DOWN TO A THIRD HOSPTIAL, THE HOSPITAL IN WHICH THEIR THORACIC SURGERY HAD BEEN PERFORMED, FOR EVALUATION AND MGMT BY TREATING PHYSICIANS OF THE EMPYEMA FOUND DURING THE THORACENTESIS IN THIS FACILITY. DISCUSSIONS WITH THE PULMONOLOGIST AND THE ASSISTING NURSE REVEALED THAT THERE HAD BEEN NO PROBLEM WITH ANY OF THE EQUIPMENT USED DURING THE BRONCHOSCOPY. WHEN THE PROCEDURE HAD CONCLUDED, THE SMALL AMOUNT OF BLOOD AROUND THE PT'S NARES WAS EASILY CLEANED; THIS WAS NOT AN UNUSUAL OCCURRENCE. THEY INDICATED THAT THE PT HAD NOT EXPERIENCED ANY SHORTNESS OF BREATH OR DISCOMFORT DURING OR AFTER THE PROCEDURE. ADDITIONALLY, NO DEFECTS WERE IDENTIFIED BY THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPT. IT IS PRESUMED THAT SINCE THIS WAS THE FOURTH BRONCHOSCOPY UNDERGONE BY THE PT, THAT THE BLEEDING WAS RELATED TO DISLODGEMENT OF SCAR TISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 THERAPEUTIC BRONCHOSCOPE BRONCHOSCOPE EQN PENTAX PRECISION INSTRUMENT CORPORATION EB 1830T3 *

Patients

Seq Age Sex Outcome Treatment
1 74 YR Required Intervention #: PVM-1343MD.| #: PVH-2030.| 1. EQUIPMENT: VIDEO PROCESSOR, MFR: PENTAX| 2. EQUIPMENT: PASSPORT TWO, MFR: DATASCOPE, MODEL| 4. EQUIPMENT: TRINITRON MONITOR, MFR: SONY, MODEL| #: CM11960.| INSTRUMENTS, MODEL #: EPM3300.| 5. EQUIPMENT: MAVIGRAPH, MFR: SONY, MODEL #:| UP5200MD.| 3. EQUIPMENT: TRINITRON MONITOR, MFR: SONY, MODEL