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 Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After a 1 gland cytopunction, impossibility to take the needle out of the sheath for prelevement.Exam length increase, necessity to use a second needle.Stress added on operator as they were afraid of product integrity.They had to cut the sheath to access the needle.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Supplemental follow up report is being submitted because answers to additional questions were received on 25-jan-2022: why did the user need to cut the sheath? was it cut before removal from patient? -they cut the sheath because he could not take out the needle and the removal of the sheath following the first puncture, to check on the needles was intact and that there was not left a needle tip into the patient.

Manufacturer Narrative

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

Event Description

Supplemental follow up report is being submitted due to the receipt and evaluation of the complaint device on the 04-mar-2022.The investigation was concluded on the 29-mar-2022, this supplement report includes the investigation conclusions also.

Manufacturer Narrative

Pma/510(k) # k160229.1 unit of lot c1857684 of echo-hd-22-ebus-o was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation.The device was returned with the sheath cut.A proximal kink below the sheath extender was observed.Another kink was observed approx.18.5cm from the needle tip.Prior to distribution, all echo-hd-22-ebus-o 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.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1857684 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 c1857684.The notes section of the instructions for use, 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.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.As no additional information was shared a possible root cause is difficult to be determined but could be attributed to the device being used in a flexed or twisted position during the procedure causing the needle to kink below the sheath extender and approx.18.5cm from the needle tip.These kinks would have led to the needle removal difficulties encountered and the user having to cut the sheath to check the needle was intact.Additionally, a possible root cause may be attributed to damage during set up, insertion/advancement down the scope resulting in the needle kinking.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13076302
• MDR Text Key: 288202819
• Report Number: 3001845648-2021-00897
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)240811(10)C1857684
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2024
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1857684
• 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: 12/03/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/06/2021; 12/06/2021
• Supplement Dates FDA Received: 02/22/2022; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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