MAUDE Adverse Event Report: COOK MEDICAL IRELAND ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM; ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE

Catalog Number	ECHO-PPG
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #den180062.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Per rep - 13jun2024 - the device was giving some erroneous readings for the hepatic and portal pressure.When moving the manometer, the numbers would move around.The procedure was successfully completed with the device in question.
Event or Problem Description
A supplemental report being submitted due to completion of investigation on 23-jan-2025.
Additional Manufacturer Narrative
Device evaluation the device, connecting tube and transducer of lot: c2161360 of echo-ppg was returned opened in its original packaging.The transducer was shipped to the supplier for investigation.The transducer related to this occurrence underwent a laboratory evaluation by the supplier centurion.The returned device lab findings and observations can be referred through the attached file.Transducer evaluation.The sample was forwarded to centurion's engineering team, who performed a pressure accuracy test and confirmed the returned sample was able to measure pressure accurately from 0mmhg to 900mmhg.The sample evaluation was unable to confirm the reported issue.There seems to be no evidence in the file of any mention of such a kink.If this kink was not observed before shipping the device back to cirl then it can be assumed that the kink would have occurred in the transport returns process.¿ reply was received as follows: ¿the kink was not observed before the procedure, otherwise the device would not have zero¿d properly.It likely occurred after the procedure.¿.As per customer confirmation the proximal kink below the sheath extender could have occurred during transportation /device returns process.Manufacturing records prior to distribution, all echo-ppg devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-ppg of lot number: c2161360 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the warnings section of the instructions for use, ifu0123 which accompanies this device instructs the user to; "visually inspect the device with particular attention to kinks, bends and breaks.If a device abnormality is detected that would prohibit proper working condition, do not use¿, and the system preparation section: ¿identify the patient¿s phlebostatic axis and level the transducer at this point.Caution: position the transducer at this level while obtaining the pressure measurements.Any movement will change current or subsequent pressure measurements.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0123) image review an image was not returned for evaluation.Root cause analysis definitive root cause was established.The user has not complied with the requirements of the ifu and/or label.As per information in description of event ¿when moving the manometer, the numbers would move around.¿ the complaint was described as giving erroneous readings when the device was moved.This is expected, the physiological pressure may change at different locations, or when the needle is moved, the device is meant to be static, and readings taken without the device moving.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Summary complaint is confirmed based on visual and/or functional inspection.No patient outcome information was shared.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
• Common Device Name: ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE
• Manufacturer (Section D): COOK MEDICAL IRELAND; cook medical ireland; o halloran road; limerick
• Manufacturer (Section G): COOK MEDICAL IRELAND; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19719178
• Report Number: 3001845648-2024-00363
• Device Sequence Number: 15501435
• Product Code: QIJ
• UDI-Device Identifier: 00827002465602
• UDI-Public: (01)00827002465602(17)260430(10)C2161360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: ECHO-PPG
• Device Lot Number: C2161360
• 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: 06/13/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown