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 Separation Problem (4043)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Northgate technologies, inc was made of the alleged issue on 16th august 2021, that the physician had to use additional intervention to remove an expelled probe tip into pancreatic duct.The patient did not incur any injury with no health consequences or impact from the procedure.The intended use of the autolith touch probes are for the use of fragmentation of biliary calculi (stones that located in the cystic duct, hepatic ducts and common bile duct) when used in conjunction with a lithotriptor.The potential for an injury from a completely broken off tip into the pancreatic duct has not been evaluated in a clinical setting.The number of ehl pulse activations delivered is unknown at the time of tip expulsion and this information was not available from the customer.The tip detaching itself from the probe is a known failure mode of the probe and expected probe life about 1,200 pulses.The tip being expelled within the biliary / urinary system has been assessed and deemed acceptable as the tip size can be expelled from those areas naturally without any harm to the patient.This event is being reported as a device malfunction given that the injury reported did not meet the criteria for a serious injury per 21 cfr 803 but the event as reported reasonably suggests that the device malfunctioned and that the device or a similar device marketed by the manufacturer could cause or contribute to a death or serious injury if the malfunction were to recur depending on the location of the malfunction and other contributing factors.The device history record for lot number bsc15166 from march of 2021 (manufacturing order 15166) was reviewed and the lot passed all testing.During production when the load returned from the sterilizer 7 cartons were noted to have incurred some damage at the sterilizer or in transit by the shipper.Manufacturing performed 100% sort on the entire load to identify any other non-conforming product.The discrepant probe cartons were repackaged into new cartons if the probe sterile pouch barrier was intact and if there was no damage noted to the probes as a result.No adverse effect on the product as a result.This is the first occurence that nti is aware of a tip being expelled during off-label use of the probe in the pancratic duct which could result in an increased risk to the patient.This type of use will be trended and the risk analysis may be updated if warranted.The alleged probe is expected to be returned to nti for further investigation under capa (b)(4).On 9/14/2021 the distributor indicated that this product is no longer expected to be returned.If this product is returned nti will investigate the product under capa (b)(4) and any additional findings will be updated via a follow-up report.

Event Description

On 16aug2021, northgate technologies, inc was made aware of the alledged event, ".It was reported that: dr [redacted] then had to use a basket to remove the broken tip from the pancreatic duct.As far as we are aware at the present moment, the patient did not incur any injury.But, there was potential for injury to the patient from the probe tip being completely broken off (fortunately dr noticed something "black floating" around in the patients pancreatic duct and was successfully able to remove it).".

• 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: 12475857
• MDR Text Key: 271526352
• Report Number: 0001450997-2021-00006
• Device Sequence Number: 1
• Product Code: FFK
• 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: distributor,health profession
• Type of Report: Initial
• Report Date: 08/16/2021

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: No Information
• Device Expiration Date: 03/01/2024
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: BSC15166
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention