MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-O

Device Problems Break (1069); Fracture (1260)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Cough (4457); Gastrointestinal Hemorrhage (4476)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k160229.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations via phone conversation "the physician retracted the scope and noticed the needle had broken-off.The physician went back-in and could not find the broken piece.The patient actually coughed-out the broken portion of the needle (while the patient was in the recovery area - after extubation / pulling the air way out)".Note: removal of the needle through the scope met resistance.The physician is requesting what type of metal the needle is made of.I contacted the dm (via phone conversation) and provide him with the customer's contact info.He stated he will follow up with the customer accordingly to answer their questions.Did any unintended section of the device remain inside the patient¿s body? not the customer is aware of (however it is possible as there could be a potential fragment still remaining).Please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? no.Please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? minimal bleeding and coughing.Has the complainant reported that the product caused or contributed to the adverse effects? yes.Please specify adverse effects and provide details.

Manufacturer Narrative

Pma/510(k) # k160229.Device evaluation: complaint device was not returned therefore a document based review will be performed.Document review including ifu review: prior to distribution, all echo-hd-22-ebus-o devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1892766 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1892766.The notes section of the instructions for use, ifu0051-8, which accompanies this device instructs the user to inspect the device prior to use: "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 (ifu0051-8).Root cause review: a definitive root cause could not be determined from the available information.As there was no additional information shared a possible root cause is difficult to determine but could be attributed to advancement into a hard lesion or through hard tissue such as cartilage causing the distal tip of the needle to break.It could also be due tortuous anatomy requiring flexed endoscope position and extreme angulation resulting in the distal part of the needle breaking.Summary: complaint is confirmed based on customer¿s testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence as minimal bleeding and coughing was reported.It was confirmed that the broken needle part was coughed out by the patient.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND 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: 14166805
• MDR Text Key: 289745579
• Report Number: 3001845648-2022-00238
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)241202(10)C1892766
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1892766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG