FDA.reportPublic FDA data

MAUDE MDR 7461499

MDR report key
7461499
Report number
2411512-2018-00003
Event key
0
Event type
3
Date of event
2018-04-03
Date received
2018-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PATRICE MARCHILDON
Address
155 PINELAWN ROAD, SUITE 230N MELVILLE NY 11747 US
Phone
516-516-5163
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROTOCOL COLON INSUFFLATOR, MODEL 6400PROTOCOL COLON INSUFFLATOR, MODEL 6400E-Z-EM INC.FCX6400N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-2501. H

Event Narratives#

N

Patient 1

ON 25-APR-2018: INITIAL AND FOLLOW UP REPORT WAS SUBMITTED TO FDA TOGETHER AS ONE SINGLE REPORT.

D

Patient 1

ON 06-APR-2018: CASE DESCRIPTION: THIS SPONTANEOUS CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL TO BRACCO IMAGING (B)(4) AND FORWARDED TO (B)(4) (OPERATING ON BEHALF OF BRACCO) ON 06-APR-2018. THE CASE DESCRIBES THE OCCURRENCE OF A COLON PERFORATION IN A (B)(6) FEMALE PATIENT WHO UNDERWENT A VIRTUAL COLONOSCOPY WITH THE PROTOCOL COLON INSUFFLATOR (MODEL 6400, SERIAL (B)(4), LOT NUMBER UNKNOWN) DUE TO THE INVESTIGATION OF HAEMOGLOBIN LEVEL VARIATION. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED AN UNSPECIFIED COLIC PROBLEM TEN YEARS AGO, RECTAL TUMOR TREATED WITH SURGERY, PELVIC TUMOR TREATED WITH RADIOTHERAPY AND ANAEMIA WHICH WAS DETECTED DURING THE LAST AMBULATORY CONTROL OF CARDIAC DISEASE. CONCOMITANT ILLNESSES INCLUDED A NON-SPECIFIED CARDIAC DISEASE AND ABNORMAL HAEMOGLOBIN LEVELS. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT WAS TREATED FOR THE EVENT WITH SURGICAL INTERVENTION. ON AN UNKNOWN DATE, THE PATIENT WENT TO THE HOSPITAL FOR AN UNSPECIFIED REASON. ON (B)(6) 2018, THE PATIENT UNDERWENT A VIRTUAL COLONOSCOPY WITH THE PROTOCOL COLON INSUFFLATOR. THE PROCEDURE WAS NOT PLANNED IN ADVANCE, THE PATIENT CAME TO THE HOSPITAL FOR ANOTHER UNSPECIFIED REASON. THE PATIENT HAD REFUSED A COLONOSCOPY UNDER GENERAL ANAESTHESIA; THEREFORE, THE VIRTUAL COLONOSCOPY WAS PLANNED. ON (B)(6) 2018, THE COLONOSCOPY PROCEDURE WAS STARTED BY A SENIOR RADIOLOGIST ACCORDING TO THE LOCAL USUAL MODALITIES. THE BALLOON WAS FILLED WITH 80 ML OF AIR. THE INSUFFLATION WAS STARTED SLOWLY AT THE BEGINNING AS USUAL, AND AT A CERTAIN MOMENT, THE PRESSURE DECREASED AND THE PATIENT COMPLAINED OF ABDOMINAL PAIN. AN ABDOMINAL COMPUTERISED TOMOGRAPHY (CT) SCAN WAS PERFORMED IMMEDIATELY AND A COLON PERFORATION (SERIOUSNESS CRITERION: HOSPITALISATION) WAS IDENTIFIED. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE SURGERY DEPARTMENT FOR SURGICAL INTERVENTION. THE STATUS OF THE PATIENT HAS IMPROVED SINCE THE SURGERY. THE PATIENT WAS STILL HOSPITALISED ON (B)(6) 2018 DUE TO FATIGUE. NO TECHNICAL ISSUE WAS IDENTIFIED WITH THE INSUFFLATOR DEVICE OR THE DISPOSABLE BALLOON (BATCH NUMBER NOT AVAILABLE). THE DISPOSABLE BALLOON WAS DISCARDED. THE SAME DEVICE WAS USED DURING A FEW EXAMINATIONS AFTER THE INCIDENCE, WITHOUT ANY ISSUES. THE INSUFFLATOR WAS THEN PLACED IN QUARANTINE AND AN INVESTIGATION BY THE MANUFACTURER WAS REQUESTED BY THE REPORTER. ACCORDING TO THE RADIOLOGIST WHO PERFORMED THE EXAMINATION, THE ISSUE IS RATHER RELATED TO THE CANNULA POSITIONING THAN TO A DEFECT OF THE PROTOCOL COLON INSUFFLATOR. THE RADIOLOGIST ALSO STATED THAT THE HISTORY OF RADIOTHERAPY MIGHT HAVE LED TO FRAGILIZATION OF THE DIGESTIVE WALL, WHICH WAS A RISK FACTOR FOR THE COLON PERFORATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 13-APR-2018: FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTING RADIOLOGIST AT BRACCO IMAGING (B)(4) AND FORWARDED TO (B)(4) ON THE SAME DAY. PATIENT'S MEDICAL HISTORY, HOSPITALISATION DETAILS AND THE REPORTER'S ASSESSMENT WERE UPDATED. OUTCOME: RECOVERING/RESOLVING. ADDITIONAL INFORMATION IS REQUESTED. (B)(4).