MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC.; INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE

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

Patient Problem Abdominal Pain (1685)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Northgate technologies received notification from customer boston scientific on october 30, 2020 of the alleged event.Northgate attempted to obtain further information about the causality of the event from the device in question.On 12/17 further requests for information went unanswered, therefore nti made the determination to submit with the information available.Even though the specific part number of the probe in this report is unknown the (b)(4) risk analysis for autolith touch/uro-touch/bsc autolith touch & associated ehl disposable probes was reviewed, as this is likely an autolith touch probe.Section 7.4.12 refers to the risk of post-operative complication due to patient injury from bleeding.The operators manual contains a warning regarding bleeding.The risk of death or serious injury from the stated issue is remote.Items 7.1.11(a) and (b) refers to the risk of perforation of the biliary ductal system the operators manual contains a warning that the device should be operated by experienced people and to not place the probe against tissue.A clinical evaluation was performed per (b)(4) which proved the benefits of lithotripsy outweigh the risks.The risk of death or serious injury from the stated issue is remote.This is the first report of hepatic injury after use of an autolith probe, and/or device.A follow up report will be submitted if further information is obtained.

Event Description

Northgate technologies was made aware of the following event "the ercp + spyglass procedure was performed on monday (b)(6) 2020, at clinica la costa.The patient was operated as she had a choledocholithiasis and the stone was fragmented with electrohydraulic energy (ehl).An autolith probe was used at a power of 5 medium with a total of 750 shots.The procedure was performed successfully, there were no complications reported for the patient and she was discharged after the procedure.24 hours later, the patient arrived at the emergency department due to abdominal pain, she was admitted on wednesday (b)(6) 2020 for open surgery in which it was found a liver injury, visualizing an hepatic rupture and profuse hemorrhage.The patient was hospitalized in the icu service due to the complexity of the case.".

• 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: 11033251
• MDR Text Key: 223379954
• Report Number: 0001450997-2020-00009
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization