MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM; Endoscopic transhepatic venous access needle

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: (b)(6).Pma/510(k): d362689.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Bent needle but still could be used; not satisfied with quality and performance of device on (b)(6) 2022 the patient underwent endoscopic ultrasound-guided portosystemic pressure gradient measurements using the echotip insight measurement system while under general anesthesia.The portal vein was accessed transduodenal.The diameter of the target segment of the portal vein measured 10 mm.The average portal vein measurement was 21 (mmhg).The hepatic vein access site was not provided.The diameter of the target segment of the hepatic vein was not provided.The average hepatic vein (pressure) measurement was 11.3 (mmhg).The final echotip portal pressure gradient measurement was 10 (mmhg).Additional procedures included liver biopsy.Procedure was complete and the patient did not experience any medical problems.This file will capture off label use of the echo needle for liver biopsy.

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 returned for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: n/a.Document 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 number is unknown a review of manufacturing records could not be performed.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".There is evidence to suggest that the customer did not follow the instructions for use as the device was used in the liver which would be considered off label use.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.Root cause review: a definitive root cause for the customer complaint could be attributed to off-label use as the device was used in the liver which would be considered off label use as per ifu this device is used "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 the customers 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 on 28-dec-2022 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: 15509449
• MDR Text Key: 300904689
• Report Number: 3001845648-2022-00677
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

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: UNKNOWN
• Device Lot Number: C1875252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female