MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP INSIGHT ENDOSCOPIC ULTRASOUND NEEDLE; ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE

Catalog Number ECHO-PPG-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/31/2023

Event Type  Injury  

Event Description

16-11 patient (b)(6) ¿ vascular injury the pre-procedure clinical assessment from (b)(6) 2023 (the day of procedure) showed that the patient did not have hepatic encephalopathy.The patient did have ascites in severe grade (grade 3).The patient had a child-pugh score at 8 and the patient is a tips patient.The patient did have beta blockers (medication) within the 72 hours before procedure.The pre-procedure lab work, completed the day of procedure, revealed a total bilirubin of 1.9 mg/dl an albumin of 30 g/l, a platelet count of 60 10^9/l, a creatinine of 0.61 mg/dl, an inr of 1.3, a sodium of 139 mmol/l, an estimated glomerular filtration rate (egfr) (ml/min/1.73m^2) of 90 and a polymorphonuclear neutrophil (pmn) (mm^3) of 120.On (b)(6) 2023, during the index procedure, the echotip insight measurement system was used on the patient.The patient did have prophylactic antibiotic for the procedure.Under the procedure it was shown the patient had varices classification ev (ov): isolated esophageal varices, the largest varix was on 7 mm.The patient also had a mild portal hypertensive gastropathy - mosaic-like pattern of mild degree (without redness of the areola).The left portal vein was accessed transgastric.The puncture portal vein puncture location was intrahepatic.The portal vein vessel puncture was achieved and it was easy to visualizing needle in vessel.The middle hepatic vein was accessed transgastric.The puncture location was intrahepatic.The hepatic vein assessment was neither easy nor difficult to visualizing target hepatic vein.The hepatic vein vessel was punctured and the visualizing needle in vessel was easy.It was very easy to obtain the hepatic vein measurement.The height of the compass ct transducer did not change during the period of pressure measurements (from the first pressure measurement to the last pressure measurement).The compass ct transducer did not change location compared to the phlebostatic axis during the period of pressure measurements (from the first pressure measurement to the last pressure measurement).Under the procedure a biopsy was performed.The treating physician was satisfied with the quality and performance of the device (echotip insight measurement system).The patient did not experience any significant medical problems, during the procedure.Post-procedure on the same day as the procedure the patient did not have any significant medical problems and the patient did not get any medication post-procedure.On the (b)(6) 2023 (1 day post-procedure), the follow-up clinical assessment was completed.The patient did not take any medication.The patient did have a significant medical problem, which lead to a serious deterioration in health that resulted in in-patient or prolonged hospitalization.On the (b)(6) 2023, the patient experienced an adverse event with vascular injury, specified by the site as: ¿laceration of the tunica intima of the portal vein¿.The was not treated at this time.The site considered the event to be probable related to the needle (echo-ppg-25).The site described ¿laceration could be done by the needle when puncturing repeatedly¿.The site considered the event to be probable related to the study procedure, and again described it ¿laceration could be done by the needle when puncturing repeatedly¿.The site also considered the event to be probable related to another portion of the procedure, the tips procedure.The site described ¿the catheter was not well placed and could have worsened the injury¿.The site considered the event was not caused or contributed by any pre-existing condition, new condition, or circumstances.The event did lead to a serious deterioration in health that resulted in in-patient or prolonged hospitalization.The site indicated that the event did not occur due to a deficiency with any of the echotip insight measurement system components.A query has been created, since the site have assessed the event of being probable related to the needle (echo-ppg-25).The study is ongoing, and the patient remains in the study.Additional information received on 11-sep-2023: hi complaints teams, this event, has been updated with information from the site: the site changed the answer from no to yes for the question: did the event occur due to a deficiency with any of the echotip insight measurement system components? the site specified it was the needle (echo-ppg-25), but also described the deficiency: ¿the endoschopist had to repeat the puncture many times.It could be due to the needle but it is most probable to be because of the difficult anatomy of the patient's veins.¿.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # den180062.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.There are two methods by which pmcf complaints are received; 1.Initial/ final pmcf report in a pdf format - this is emailed by cook research team.2.Research team can directly ask customer service to open complaints on trackwise for any ongoing clinical studies - so they open these complaints as and when they come across the malfunction/ adverse events.The studies usually go on for many months or even years.So the research team might not have a report drafted in this case, they would just call in customer service to log these complaints pr 407717 falls under type 2 above.Manufacturing records: prior to distribution, all echo-ppg-i devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-ppg-i of lot number c2038813 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label: as per the instructions for use, ifu0131 damage to blood vessels is a known adverse event which informs the user about the potential adverse events "those associated with an endoscopic ultrasound procedure include: allergic reaction to medication, aspiration, cardiac arrhythmia or arrest, death, fever, hypotension, infection, pain/discomfort, perforation, respiratory depression or arrest¿.¿those associated with the device include: arteriovenous fistula, cholangitis, damage to blood vessels, embolism, fever, hemorrhage, hypotension, infection, inflammation, nerve damage, pain/discomfort, perforation, pneumoperitoneum, sepsis, septicemia/bacteremia, thrombosis, vessel occlusion, vessel trauma¿.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.However, there was no evidence of a failure reported associated with the actual device.Laceration of the tunica intima of the portal vein can be covered by ¿damage to blood vessels¿ as a known potential adverse event.As per medical affairs a potential root cause could be attributed to the tips procedure with a catheter might have likely damaged the tunica intima.Another possible root cause could also be attributed the difficult anatomy of the patient's veins as per information detailed in the patient/event info ¿ notes section.Summary: complaint is confirmed based on customer and/or rep testimony.The event did lead to a serious deterioration in health that resulted in in-patient or prolonged hospitalization.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 09-jan-2024.

• Brand Name: ECHOTIP INSIGHT ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE
• 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: 17859657
• MDR Text Key: 324777065
• Report Number: 3001845648-2023-00750
• Device Sequence Number: 1
• Product Code: QIJ
• UDI-Device Identifier: 00827002580008
• UDI-Public: (01)00827002580008(17)230930(10)C2038813
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: ECHO-PPG-25
• Device Lot Number: C2038813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG