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

Catalog Number ECHO-HD-19-A

Device Problems Material Perforation (2205); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k092359.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The customer reported: "the doctor could not aspirate fluid through the first needle, as it bent easily.((b)(4)).The second needle stiffened and the doctor punctured the scope when taking a specimen of the duodenal bulb.((b)(4))".

Manufacturer Narrative

Complaint device was not returned therefore a document based review will be performed.It should be noted that this file is related to another complaint file.For details of the other investigation please refer to (b)(4) (reference 3001845648-2019-00763).Distal rather than proximal kink will be assessed for the purpose of risk, it is possible that a distal kink may have occurred during puncture causing issues with aspiration.Prior to distribution, all echo-hd-19-a 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 number is unknown the device history records could not be reviewed as part of the investigation.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".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.No answers to the standard additional questions were received making it very difficult to determine a potential root cause.Based on the very limited information shared a possible root cause could be attributed to advancement into a hard lesion causing a distal kink to the needle which then resulted in the aspiration difficulties.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

The customer reported: "the doctor could not aspirate fluid through the first needle, as it bent easily.The second needle stiffened and the doctor punctured the scope when taking a specimen of the duodenal bulb.(reference 3001845648-2019-00763).

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9494436
• MDR Text Key: 220058026
• Report Number: 3001845648-2019-00762
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K092359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1