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 Puncture/Hole (1504); Structural Problem (2506)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

At the moment to do the punction, the mandrel pierced the sheath of the needle.Indeed the doctor was not able to go ahead with the punction.And when they took off the product the mandarin did not go out the proper place and pieced the sheath."as per context translation": when performing the puncture, the needle (the mandrel) pierced the needle¿s sheath.In effect, the physician was unable to proceed with the puncture and when he removed the device, he noticed that the mandrel did not come out in the right place, it pierced the sheath.Device replaced.Incident classification : other type of incident resulting in a notification clinical consequences and current status of the patient of person involved : temporary consequences: the procedure took longer because a new device had to be used.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow up mdr is being submitted to capture the lab evaluation: complaint device was returned and evaluated on 04-mar-2022: visual inspection: very slight damage to the distal end of sheath.Functional inspection: sheath extender able to advance and retract with no issue.Needle able to advance and retract with no issue.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 05-apr-2022.

Manufacturer Narrative

Device evaluation: the echo-hd-19-a device of lot number c1864024 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 04th mar 2022.S.Very slight damage to the distal end of sheath was observed.The sheath extender was able o advance and retract with no issue.The needle was able to advance and retract with no issue.Document review: 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.A review of the manufacturing records for echo-hd-19-a of lot number c1864024 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 c1864024.The notes section of the instructions for use, ifu0050 which 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 condition, do not use¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0050) image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.It is possible that the sheath section distal to the needle and stylet was in a bent position with caused the stylet to pierce the sheath at the distal end.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated 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 trend.

• 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
• 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: 13706685
• MDR Text Key: 296884465
• Report Number: 3001845648-2022-00126
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520124
• UDI-Public: (01)10827002520124(17)240901(10)C1864024
• Combination Product (y/n): N
• PMA/PMN Number: K092359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• 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: C1864024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2022
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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