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

Catalog Number ECHO-HD-22-C

Device Problems Kinked (1339); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

The device was used for eus-fna.The needle was advanced into the cancer lesion in the pancreatic head through the stomach.At the first biopsy attempt, the needle could advance into the target site, but could not be retracted back into the sheath.The device was removed from the endoscope with the needle sticking out.Since specimen was aspirated at the first attempt, the procedure was finished with no additional treatment.There have been no adverse effects to the patient reported.The complaint issue was reported as follows: "the device was used for eus-fna.The needle was advanced into the cancer lesion in the pancreatic head through the stomach.At the first biopsy attempt, the needle could advance into the target site, but could not be retracted back into the target site, but could not be retracted back into the sheath.The device was removed from the endoscope with the needle sticking out.Since specimen was aspirated at the first attempt, the procedure was finished with no additional treatment." there were no echo-hd-22-c (echo) devices of lot #c936246 in stock at the time of the complaint investigation.The echo device involved in this complaint was not returned for evaluation.With the information provided a document based investigation was carried out.The complaint information reported indicated that the needle was kinked from the needle tip to core trap.This kink most likely prevented the retraction of the needle into the sheath.A possible cause of the needle tip becoming kinked may be attributed to individual patient anatomy if the are being sampled with a particularly hard mass or lesion.It is also possible the distal needle tip was damaged due to product handling when advancing/removing the device from the endoscope and during sample retrieval.As the device was not returned for evaluation and the actual use conditions cannot be replicated in the laboratory we are unable to conclusively determine the cause of this complaint.Prior to distribution, all echo devices are subjected to functional checks and visual inspection to ensure device integrity.This includes an inspection of the device for kinks.A review of the manufacturing records for echo device of lot number specified above did not reveal any discrepancies related tot he complaint issue.The notes sections of the instructions for use that accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working conditions, do not use." the patient did not experienced any adverse effects due to this occurence.The customer complaint was confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

The user has indicated the needle could not be retracted during use.This complaint is reportable to the fda on the basis of a previous adverse event for an echo-hd-19-c.The reporting precedence covers the entire product family.Therefore, all echo devices involving a proximal needle breakage and or the non retraction of the needing reportable regardless of patient outcome.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; UK
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3755923
• MDR Text Key: 20270382
• Report Number: 3001845648-2014-00024
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2016
• Device Catalogue Number: ECHO-HD-22-C
• Device Lot Number: C936246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• 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 Age: 60'S