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 Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User checked the target area after biopsy and found out there was a broken needle tip inside patient.User suspected the broken needle was stuck inside the sheath during biopsy.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted because complaint device was returned and evaluated on 11-jul-2022: visual inspection: - broken needle tip returned separately (approx.2.4cm in length) - distal end of needle examined and no issue observed - proximal kink below the sheath extender observed - evidence of blood on distal end of needle.- mlla examined and observed to be off-center.Functional inspection: - sheath extender able to retract with difficulty and unable to advance.- needle able to advance with a lot of difficulty - retracted needle handle but distal end of needle did not retract into the sheath.- needle removed from device and needle break observed approximately 98cm from base of needle hub.- diameter of broken needle tip which was returned separately was measured, dimension 0.042 inches - diameter of distal end of needle from device returned measured, dimension 0.036 inches.

Manufacturer Narrative

Cancellation report submitted as the investigation proved a cook device did not cause or contribute to the event.

Event Description

Cancellation report being submitted due to additional information received confirming a cook device was not the complaint device involved.

• 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: 14117008
• MDR Text Key: 289314646
• Report Number: 3001845648-2022-00228
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)221105(10)C1665755
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1665755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2019
• 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: 62 YR
• Patient Sex: Male