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

Model Number 72-00322-0

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Hepatitis (1897)

Event Date 02/11/2022

Event Type  Injury  

Event Description

On 21feb2022, northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation ".After less than 24 hours the subject had an episode of cholangitis.The adverse event is serious since the outcome will result in prolonged hospitalization.The relationship with our procedure is probable.A cholangiography was performed on (b)(6) 2022, but no residual lithiasis was observed.The biliary drainage was replaced.The subject was treated with antibiotic therapy and is fine".There was no alleged device malfunction during the ehl procedure.

Manufacturer Narrative

On 21feb2022, northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation ".After less than 24 hours the subject had an episode of cholangitis.The adverse event is serious since the outcome will result in prolonged hospitalization.The relationship with our procedure is probable.A cholangiography was performed on (b)(6) 2022, but no residual lithiasis was observed.The biliary drainage was replaced.The subject was treated with antibiotic therapy and is fine".There was no alleged device malfunction during the ehl procedure.There are 2 suspect devices used during the incident from different lots and are being reported separately.On 23feb2022 requested additional information from the distributor on the procedure and the suspect devices.As of 16mar2022, we have not received any additional information despite multiple requests from the end user.Capa (b)(4) was initiated to investigate the event with available information from the end user.The suspect device has been requested to be returned for investigation.The probes have not been returned for evaluation.The device history record for bsc15615 from august 2021 (mo 15615) was reviewed and the lot passed all testing.Currently there is no known or suspected malfunction noted with the suspect device given that the distributor complaint coding on the device was "no known device problem" and a review of the device history record of the lot that was involved in the incident.A follow up report will be filed with any additional information and findings when it becomes available.

• Brand Name: AUTOLITH TOUCH 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: 13793829
• MDR Text Key: 287325398
• Report Number: 0001450997-2022-00002
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: BSC15615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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): Hospitalization; Other