MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT

Catalog Number ECHO-PPG-I

Device Problem Off-Label Use (1494)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

Customer called to advice there was no accurate measure and the needle tip was bent."as per cc form": very difficult case due to the anatomy and the difficult position of the hepatic veins, the only possibility was the suprahepatic vein.When accessing it, the needle bent and the measurements given by the ct-compass were not valid.On several occasions i do not get to mark the "0".We had difficulties in calibrating the ct-compass on two occasions and we had to start over.We think that because of the forced position of the scope and the needle.The needle bent and i am no longer able to measure the ct-compass well.Another difficulty was a pressure leak through one of the connections, so we had to prepare the system from the beginning.Finally the measures we take are not accurate.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.Are images of the device or procedure available? no.Identify which device echo-ppg-i.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? patient end.N/a, handle end, patient end a.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no, was the device damaged in packaging prior to removal? no, was the device damaged on removal from packaging? ,no, was gaining access to the target site difficult? yes, was the device used in a tortuous position? no really, was puncture of the target site difficult? yes, please advise the anatomical location of the intended target site: hepatic vein.Where was the vessel targeted from? from stomach.Did the needle pass through the liver parenchyma? yes.If not with the device in question, how was the procedure performed and/or finished?.Procedure was not finish.Did the patient require any additional procedures? no.Was any secondary intervention required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure, another day.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? no.If yes, please specify what was observed and where on the device it was observed.Is it known if the patient recently tested positive for covid-19? no,.If yes, please do not return the complaint device to cirl for evaluation.Please take pictures of the defect where possible and provide these to aid the investigation.Did the transducer display a software error code? yes/no a.If yes what code?.Not accurate measure.Estimated time for transducer to stabilize?never stabilize in hepatic vein.Were air bubbles identified within the system?no.Was fluid identified leaking from the connectors?no for complaints occurring during use (once in contact with scope) also ask:.What is the scope manufacturer and model number that was used?.Pentax.Was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? no.When was the issue with the product noted? e.G.On advancement of the sheath/needle or on needle retraction? advancement of sheath, retraction of needle.Nothing.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract the needle into the sheath before removing the device from the patient?yes,.Was the scope in a flexed or twisted position at any time during the procedure?yes,.How many times was vessels accessed with this needle?3 times, i am not remember very well.Did any section of the device detach inside the patient? no yes, no if so, please specify: was there difficulty locking the sheath (or needle) in place or was slipping experienced during use? no.Was there any difficulty attaching or detaching the device to the accessory channel port on the scope? no.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? yes.

Manufacturer Narrative

Device common name: qij.Pma/510(k) # den180062.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Section d2a: common device name: qij.Section g 4.Pma/510(k) # den180062.Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-ppg 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-ppg of lot number c1772539 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 c1772539.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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".Also, step 7 of the instructions for use states ¿extend the needle by advancing the needle handle to the pre-positioned safety ring into desired vessel under ultrasound guidance, either hepatic or portal vein, or their branches¿ there is evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could be attributed to off label use.As per medical affairs ¿suprahepatic vein is the part of inferior vena cava (ivc), it is off-label use if puncturing the ivc." it is possible that the conditions brought about when using the device other than specified within the ifu may have contributed to the needle tip bending leading to the inaccurate readings of the manometer.It is also possible that using the device other than specified within the ifu may also have contributed to the pressure leak with the tube connection.Complaint is confirmed based on the customer's testimony.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.

Event Description

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

• Brand Name: ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT
• 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: 12743045
• MDR Text Key: 285683660
• Report Number: 3001845648-2021-00778
• Device Sequence Number: 1
• Product Code: QIJ
• UDI-Device Identifier: 00827002580008
• UDI-Public: (01)00827002580008(17)220131(10)C1772539
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/19/2021

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: 01/31/2022
• Device Catalogue Number: ECHO-PPG-I
• Device Lot Number: C1772539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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 Sex: Male