MAUDE Adverse Event Report: COOK IRELAND LTD ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH; FDX ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number ECHO-19-CB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

During a literature review of the paper 'sendino o, fernandez-esparrach g, sole m et al.Endoscopic ultrasonography-guided brushing increases cellular diagnosis of pancreatic cysts: a prospective study.Digestive and liver disease 2010; 42: 877-881' it was noted that there was one case of a fatal retroperitoneal haemorrhage reported of patient who had undergone an eus-guided cytology brushing procedure.The patient in this case was withdrawn from hospital 24 hours after the procedure with no symptoms.One week later she developed back pain, anaemia, and multiorganic failure that lead to death 30 days after readmission.

Manufacturer Narrative

Although no device malfunction has been reported, this incident meets the criteria of a serious injury report based on the intervention to manage the reported fatal retroperitoneal haemorrhage that developed following the use of an echobrush endoscopic ultrasound cytology brush.This complaint is related to an echo-19-cb device of an unknown lot number.The echo-19-cb device involved in this complaint has not been returned for evaluation.With the information provided, a document based investigation was carried out.The customer complaint is considered based on the customer testimony.Clinical personnel were notified of this complaint and the following comments were provided: "it is reasonable to say that the patient could have had retroperitoneal hemorrhage develop without going through the procedure.Yes, the device was used during the procedure, but that alone does not mean it contributed/caused the adverse events or that if the device was not used this condition would probably not have developed.My opinion is all of the adverse events are clinical procedure related and/or patient condition events."." as the echo device was not returned for evaluation and no specific device malfunction was noted during the procedure it is not possible to determine the root cause of this complaint however it is most likely procedure and/or patient condition related.As per the instructions for use that accompanies this device, potential complications with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.The manufacturing records of the device involved in this complaint could not be reviewed as the lot number of the complaint device was not provided.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH
• Type of Device: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; limerick ; EI ; 61334440
• MDR Report Key: 4585071
• MDR Text Key: 5454042
• Report Number: 3001845648-2015-00039
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K052279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-19-CB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention