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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Chon et al.2019- ¿endoscopic ultrasound-guided liver biopsy using a core needle for hepatic solid mass¿.This study aimed to evaluate the feasibility and efficacy of endoscopic ultrasound-guided fine needle biopsy (eusfnb) using a core needle for hepatic solid masses (hsms).Additionally, the study aimed to assess factors that influence the diagnostic accuracy of eus-fnb for hsms.Retrospective analysis of patients who underwent eus-fnb for the pathological diagnosis of hsms was conducted between january 2013 and july 2017.Fifty-eight patients underwent eus-fnb for the pathologic evaluation of hsms.After evaluation, the mass was punctured using a 20-g, 22-g or 25-g core needle (echotip procore® hd ultrasound biopsy needle; wilson-cook medical inc., bloomington, in, usa).The needles used were 20-g (n=14), 22-g (n=29), or 25-g core needle (n=15).Procedure-related complications occurred in only one case of hemorrhaging (1.7%), which was successfully managed by endoscopic hemostasis.The exact rpn cannot be confirmed this file is capturing 20g, 22g or 25g echotip procore_ hd ultrasound biopsy needles.

Event Description

Chon et al.2019- ¿endoscopic ultrasound-guided liver biopsy using a core needle for hepatic solid mass¿ this study aimed to evaluate the feasibility and efficacy of endoscopic ultrasound-guided fine needle biopsy (eusfnb) using a core needle for hepatic solid masses (hsms).Additionally, the study aimed to assess factors that influence the diagnostic accuracy of eus-fnb for hsms.Retrospective analysis of patients who underwent eus-fnb for the pathological diagnosis of hsms was conducted between january 2013 and july 2017.Fifty-eight patients underwent eus-fnb for the pathologic evaluation of hsms.After evaluation, the mass was punctured using a 20-g, 22-g or 25-g core needle (echotip procore® hd ultrasound biopsy needle; wilson-cook medical inc., bloomington, in, usa).The needles used were 20-g (n=14), 22-g (n=29), or 25-g core needle (n=15).Procedure-related complications occurred in only one case of hemorrhaging (1.7%), which was successfully managed by endoscopic hemostasis.The exact rpn cannot be confirmed this file is capturing 20g, 22g or 25g echotip procore_ hd ultrasound biopsy needles.

Manufacturer Narrative

510(k) number is: k142688.The unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article.Reference "19 chon ¿ endoscopic ultrasound-guided liver biopsy using a core needle for." complaint file (b)(4) was opened to investigate one case of haemorrhaging which this file will investigate as the rpn and lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo tip procore devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, 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, damage to blood vessels, nerve damage, and acute pancreatitis.Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seeding of the needle tract.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual device.As per the ifu potential complications include hemorrhage.As per medical affairs "the needle will definitely cause some degree of bleeding which is inherent in the procedure.However, the bleeding was procedure related as stated in the article".Complaint is confirmed based on customer testimony.The patient outcome is unknown, one case of haemorrhaging as reported.Successfully managed by endoscopic hemostasis.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This correction supplemental follow-up is being submitted because the complaint record was re-opened since annex a code was updated from a26 to a24 on (b)(6) 2022.

Manufacturer Narrative

510(k) number is: k142688.Device evaluation: the unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article."19 chon ¿ endoscopic ultrasound-guided liver biopsy using a core needle for".Complaint file was opened to investigate one case of haemorrhaging which this file will investigate.Lab evaluation ¿ n/a.Documents review including ifu review: as the rpn and lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo tip procore devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, ifu0077-4 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, damage to blood vessels, nerve damage, and acute pancreatitis.Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seeding of the needle tract.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual device.As per the ifu potential complications include hemorrhage.As per medical affairs "the needle will definitely cause some degree of bleeding which is inherent in the procedure.However, the bleeding was procedure related as stated in the article".Summary: complaint is confirmed based on customer testimony.The patient outcome is unknown, one case of hemorrhaging as reported.Successfully managed by endoscopic hemostasis.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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10211536
• MDR Text Key: 202944577
• Report Number: 3001845648-2020-00376
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• 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: 01/12/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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