MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-3-20-C

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

Patient Problems Cyst(s) (1800); Perforation (2001)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k142688.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Crino 2021 , endoscopic ultrasound¿guided fine-needle biopsy with or without rapid on-site evaluation for diagnosis of solid pancreatic lesions: a randomized controlled non-inferiority trial.Description of procedure + malfunction/injury as outlined in below table: 771 included patients were randomly assigned to undergo eus-fnb or eus-fnb+rose.Eus procedures were performed by expert endosonographers without involvement of trainees.Once the target lesion was visualized on eus, interposed vessels were excluded using color doppler.Selection of needle type (22g sharkcore [medtronic, minneapolis, mn], 22g acquire [boston scientific, marlborough, ma], or 20g procore [cook medical, bloomington, in]) and sampling technique (eg, suction, slow-pull, or wet suction) were left at the discretion of the endosonographer.In the eus-fnb+rose arm there was 1 pancreatic leak with pseudocyst formation treated endoscopically, this file will capture the 1 case of pancreatic leak with pseudocyst formation that potentially occurred with the cook 20g procore needle in the us.Treated endoscopically.The study cohort was made of 771 randomized patients (men, 56.4%; mean age, 67.5 ± 11.5), of whom 385 were allocated to the eus fnb+rose arm and 386 to the eus-fnb alone arm.No differences in patient demographics and clinical characteristics were observed.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 12-may-2022.

Manufacturer Narrative

Pma/510(k) # k142688.Device evaluation: the echo-hd-3-20-c device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review including ifu review: as the lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all echo-hd-3-20-c devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The potential complications section of the instructions for use, which accompanies this device states that the potential complications 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, damage to blood vessels, nerve damage, and acute pancreatitis.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 for the pancreatic leak with pseudocyst formation could be attributed to the procedure.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patients were treated endoscopically.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13042726
• MDR Text Key: 282488451
• Report Number: 3001845648-2021-00884
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2021
• Event Location: Hospital
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male