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 Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 08/05/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 northgate technologies, inc was made aware of an alleged event from distributor boston scientific, "per cnf, it was reported that: spyds+ehl was performed on a case of accumulated stones of common bile duct stones, but after the surgery bile duct perforation was suspected, and the next day ct showed the diagnosis with a bile duct perforation, so an emergency surgery was performed promptly.It was thought that the cause of the perforation was caused by the ehl probe coming into contact with the bile duct wall several times.Fortunately, the patient was not in a severe situation and the patient recovered.It was said that, looking at systematic reviews overseas, perforation occurs about 1-10%, so i felt that care should be taken in cases where bile ducts are dilated by common bile duct piled stones, cases where it is impacted on the bile ducts, and cases where the bile ducts are in a vertical position with respect to ehl probes.Procedure outcome: the procedure was completed using this device.Scope used? yes guidewire used? yes generator/controller used? yes other used? unknown","endoscopic papillotomy 3.Accompanied by biliary scopic lithotripsis".Additional questions were followed up with the distributor.On (b)(6) 2022 , the distributor provided additional information there was no known device problem, the patient was not in a severe situation from the event and patient has recovered.

Manufacturer Narrative

Capa (b)(4) was initiated to investigate the event.Additional questions were followed up with the distributor which also included request for information on the lot number of the probe.On (b)(6) 2022 , the distributor provided additional information there was no known device problem, the patient was not in a severe situation from the event and has recovered.The distributor also provided the 3 most probable lots that could likely have been used in the complaint event.A device history record review is being performed against all the three probable lots.Bsc16045: manufactured may 2022.Only reject reports indicated were issued for foreign material and secondary packaging damage.All non-conforming material was scrapped.Bsc16043: manufactured may 2022.No material reject reports were initiated for this lot.Bsc15877: manufactured march 2022.Only reject report issued were issued for secondary packaging damage.All non-conforming material was scrapped.As indicated in the complaint description by the initial complainant points to probe being fired by the physician against the tissue during treatment of accumulated stone in cbd "it was thought that the cause of the perforation was caused by the ehl probe coming into contact with the bile duct wall several times" which could be the causal factor towards patient requiring emergency surgery post procedure.Labeling warns to avoid firing the probe against the tissue and to avoid injury to the patient from tissue damage or perforation.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.

• 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 60123 ; 2248562250
• MDR Report Key: 15504392
• MDR Text Key: 300797123
• Report Number: 0001450997-2022-00008
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other