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 Problem Inflammation (1932)

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' the following incident was noted; in an eus-guided cytology brushing procedure, one patient developed a haemosuccus pancreaticus which was managed conservatively.

Manufacturer Narrative

Although no device malfunction has been reported, this incident meets the criteria of a serious injury report based on the intervention to treat the reported haemosuccus pancreaticus 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 complaint is considered based on the customer testimony.Clinical personnel were notified of this complaint and the following comments were provided: "hemosuccus pancreaticus is a rare entity and estimates of its rate are based on small case series.It is the least frequent cause of upper gastrointestinal bleeding (1/1500) and is most often caused by chronic pancreatitis, pancreatic pseudocysts, or pancreatic tumors." it was the clinician's opinion that the reported adverse event was related to the clinical procedure and/or patient condition." 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 stated on 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.It was reported that the haemosuccus pancreaticus was managed conservatively.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, ; EI ; 61334440
• MDR Report Key: 4585072
• MDR Text Key: 5479496
• Report Number: 3001845648-2015-00038
• 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

• 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
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/04/2015
• 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): Required Intervention