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

Catalog Number ECHO-PPG

Device Problem Off-Label Use (1494)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

Storm et al 2022 - case studies from the frontiers of therapeutic endoscopic ultrasound in 2022.Case 4: eus and transabdominal ultrasound-guided hepatic cyst aspiration and sclerotherapy for portal hypertension.The disposable eus ppg device incorporates a 25-gauge fna needle, manometer, and noncompressible tubing.Accurate interventional radiology-guided hepatic venous pressure gradient (ir-hvpg) recordings could not be obtained because the hepatic vein (hv) was inaccessible due to distortion by hepatic cysts.Given the organ rotation that can occur after bilateral nephrectomy, the portal vein (pv) was no longer visualized in its normal location, and pressure recordings would have required transpancreatic access.Instead, pressures were obtained from the splenic vein at a site closely approximating the pv-to-splenic vein confluence, with a mean of 23 mm hg pressure recorded.With the hvs significantly compressed by hepatic cysts, the inferior vena cava (ivc) was instead accessed.Doing so required transesophageal access with needle passage near the heart.The ivc pressure measured 8 mm hg, resulting in a ppg of 15 mm hg, which indicated portal hypertension.Eus and transabdominal ultrasound were then used to aspirate a total of 255 ml from 4 cysts located near the hvs and ivc.The large cyst abutting the ivc was aspirated, resulting in a notable difference in the amount of hepatic parenchyma visualized.Although there was a lack of eus visualization of the middle and left hvs before cyst aspiration, both hvs were seen and flow was detected with pulse doppler after eus-guided cyst aspiration.After cyst aspiration, pressures were remeasured, revealing a ppg of 11 mm hg, which represents a clinically significant 27% decrease relative to the pre-cyst aspiration values, highlighting the role of the hepatic cysts in causing the patient's portal hypertension.Subsequently, we performed simultaneous transabdominal ultrasound and eus to target peripheral and central cysts, aspirating 490 ml of fluid followed by injection of 12 ml of 3% sodium tetradecyl sulfate as a sclerosant contrast injection with fluoroscopy confirmed absent communication with blood vessels and bile ducts.This file will capture the off label usage of echo-ppg used to obtain portal vein pressure by accessing the splenic vein and the ivc.

Manufacturer Narrative

Common device name: qij.Pma/510(k): d362689.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Common device name: qij pma/510(k): d362689 device evaluation the echo-ppg device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation n/a document review including ifu review 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.As the lot numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu 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".Also, ¿intended use: this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use as the device was used to obtain portal vein pressure by accessing the splenic vein and the ivc.Image review n/a root cause review a definitive root cause for the customer complaint could be attributed to off-label use as there was 1 case of the needle used to obtain portal vein pressure by accessing the splenic vein and the ivc and as per the ifu "the echotip insight portosystemic pressure gradient measurement system is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope." summary complaint is confirmed based on customer and/or rep 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 mdr report is being submitted due to the completion of the investigation on (b)(6) 2023 and an update to the investigation conclusions.

• Brand Name: ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
• 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: 15579726
• MDR Text Key: 307179881
• Report Number: 3001845648-2022-00695
• Device Sequence Number: 1
• Product Code: QIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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 Catalogue Number: ECHO-PPG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 51 YR
• Patient Sex: Male