MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC; INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE

Model Number 72-00322-0

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

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917)

Event Type  Injury  

Manufacturer Narrative

This complaint was reported due to the allegation of "13 cases of cholangitis and 2 cases of biliary hemorrhage occurred in which autolith ehl was used, and 2 cases of biliary hemorrhage required ivr due to hemorrhagic shock." the complaint details were provided after a conference in japan where the events noted above were provided in summary.Despite requests from the manufacture to gather further details, no further information is available.Without further procedural details further investigation (root cause or causality) cannot be performed.Gallstone disease and complications from biliary calculi are a common clinical problem.The clinical presentation ranges from being asymptomatic to recurrent attacks of biliary pain, requiring elective or emergency treatment.In many cases, symptoms and major complications occur due to the migration of stones into the common bile duct (cbd) and this circumstance can cause obstruction of the bile flow in the small intestine, resulting in pain, jaundice, and sometimes cholangitis.Cholangitis and pancreatitis are the main serious complications of bile duct stones as mentioned in the clinical evaluation report (nor-doc-cer-0002).The device manual contains a warning around the risks bleeding "improper use of the ehl probe could result in vessel perforation followed by bleeding and possible infection.Other complications such as vessel strictures resulting from edema and occlusions created by stone debris are also potential complications of ehl." if further information was to become available or product returned from the field for further investigation, a follow up report will be submitted at that time.This issue will continue to be monitored through the complaint and post market surveillance systems to assure patient safety.

Event Description

It was reported to northgate technologies, inc.On 09jun2023, "it was reported that: at the 105th annual meeting of the japan gastrointestinal endoscopy society (jges), it was reported that 13 cases of cholangitis and 2 cases of biliary hemorrhage occurred in which autolith ehl was used, and 2 cases of biliary hemorrhage required ivr due to hemorrhagic shock.The details are as follows: [subject]: percutaneous transhepatic cholangioscopy (ptcs)-assisted electroshock wave lithotripsy (ehl) for intrahepatic lithiasis.[background]: in the recent years, with the advent of large balloons and oral biliary cholangioscopy (pocs), it has become possible to treat many cases of common bile duct stones, however, intrahepatic stones are still often difficult to treat.Ehl under ptcs for intrahepatic stones have been performed in the hospital and the results were reported.[method]: 66 patients who underwent ehl under ptcs were included among the 139 intrahepatic stones treatment performed in the department from september 1995 to october 2022.Olympus bf260 (with the tip diameter of 4.9mm) was used until 2017, and olympus bf-xp290 (with the tip diameter of 3.1mm) was used from 2018 onwards.(1) patient background and treatment outcome, (2) factors associated with unsuccessful treatment cases, and (3) incidents of patient adverse effects were examined.[results]: (1) the median age was 67 years old (32-87) years, and the male-to-female ratio was 36:30.Postoperative reconstructed intestine was the most common cause in 50 cases (75.8%), followed by liver transplantation in 6 cases (9.1%), and others in 10 cases (15.2%).The median maximum stone diameter was 12mm (3-52 mm), the median number of stones was 5 (1-25), and the distribution of stones was one lobe in 40 cases, and both lobes in 26 cases.The median number of ehl procedures performed were 2 times (1-15 times), and the complete stone removal rate was 93.9% (62/66 cases).Complete stone removal was achieved by ehl under ptcs in 87.5% (7/8 cases) of patients who were difficult to treat by initial double-balloon endoscopy (dbe), and 97.8% (45/46 cases) of patients who were treated percutaneously from the first time.(2) there were 4 cases of unsuccessful treatment, including 2 cases in which ehl could not be performed as the scope could not be reached due to bile duct stenosis in stones after the third bile branch, and 2 cases in which it was difficult to continue treatment due to refusal of treatment or complications.(3) adverse events were cholangitis in 13 cases (19.7%), ptbd deviation in 1 case (1.5%), and biliary hemorrhage in 2 cases (3.1%).Two cases of biliary hemorrhage required ivr due to hemorrhagic shock.[conclusion]: ehl with ptcs was considered to be a useful treatment for multiple intrahepatic stones in the second and third hepatic branches etc.Although there were few serious complications, sufficient visual field should be maintained due to the possibility of hemorrhage requiring ivr.".

• Brand Name: AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
• Type of Device: INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL
• MDR Report Key: 17543274
• MDR Text Key: 321099019
• Report Number: 0001450997-2023-00005
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (y/n): N
• PMA/PMN Number: K130368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2023

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?: No
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other