MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

Catalog Number EUSN-20-CPN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

It can be noted that eusn-20-cpn devices are now obsolete, however, this device is considered 'similar' echo-20-cpn devices currently marketed in the us therefore mdr reporting criteria applicable to this event.Product code: bsp.Pma/510(k) # k030618.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.[(b)(4)].

Event Description

(b)(6) study.Title: eus-guided ethanol injection for treatment of pancreatic cancer.10 patients experienced mild bleeding after the procedure.

Manufacturer Narrative

Can be noted that eusn-20-cpn devices are now obsolete, however, this device is considered 'similar' echo-20-cpn devices currently marketed in the us therefore mdr reporting criteria applicable to this event.Product code: bsp.Pma/510(k) # k030618.The rpn is eusn-20-cpn and lot numbers for each are unknown.This file investigates mild bleeding involving 10 patients.The eusn-20-cpn devices of unknown lot number involved in this complaint were not returned for evaluation.With the information provided document based investigation was conducted.Eusn-20-cpn is now obsolete.As the eusn-20-cpn from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all eusn-20-cpn devices would have been subjected to functional checks and visual inspection to ensure device integrity as per qsi0975.A definitive root cause could not be determined from the available information.It is not clear what caused the bleeding to occur from the information provided.A possible root cause could be attributed to the nature of the device (needle) would cause inevitable bleeding, tumor itself is prone to bleeding due to the abundant vessel when punctured.Off label use would mean the device not being used as intended which in turn could potentially have caused the mild bleeding.Complaint is confirmed based on the customer's testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.-.

Event Description

Xiujiang study.Title: eus-guided ethanol injection for treatment of pancreatic cancer.10 patients experienced mild bleeding after the procedure.

• Brand Name: ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9353049
• MDR Text Key: 167327120
• Report Number: 3001845648-2019-00620
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: EUSN-20-CPN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention