MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-1-22

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

Patient Problem Pancreatitis (4481)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Facciorusso et al 2020 ¿ statins decrease the risk of acute pancreatitis after endoscopic ultrasound fine-needle aspiration of pancreatic cysts¿ we reviewed data of our series of 456 patients with sus- pected pcls evaluated by means of eus between january 2006 and july 2018.Emptying of the cyst was performed through a 22 g needle (echotip ultra, cook medical inc., bloomington, indi- ana, usa) with a central stylet (immediately removed after the procedure).A transduodenal approach was adopted in the case of pcls of the pancreatic head and uncinate process, while the trans- gastric approach was used for pcls of the body or tail.Median age was 64 years (iqr, 62¿69) and most patients were male (58.9%), without difference between groups.3 patients in the control group were classified as severe pancreatitis.Patients with serious abdominal pain were hospitalized, treated with analgesics and antibiotics, and underwent ct-scan to assess the severity of ap.In univariate logistic regression analysis, previous history of pancreatitis, cyst histology, and non-use of statins were predictors of ap incidence.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: the echo-1-22 devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article to capture 'severe pancreatitis'.Complaint files (b)(4), were opened as a result of this paper.Reference " facciorusso et al 2020".Documents review including ifu review: prior to distribution, all echo-1-22 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl as the lot numbers are unknown a review of manufacturing records could not be performed.As per the instructions for use, (ifu0101-1) which informs the user about the potential complications "those associated 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".There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, infection is listed as a complication following the use of this device.As per medical advisor, "at the moment pancreatitis can be covered by infection in general." however, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, 3 patients in the control group were classified as severe pancreatitis.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11730885
• MDR Text Key: 263924520
• Report Number: 3001845648-2021-00342
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR