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

Model Number 72-00322-0

Device Problems Break (1069); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

Patient undergoing ercp (endoscopic retrograde cholangiopancreatography) cholangioscopy with ehl (electrohydraulic lithotripsy).Four probes were used.Per attending physician: first probe broke outside of patient after use.Second probe used until it no longer worked.Third probe tip broke off.

Manufacturer Narrative

On 29jun2022, northgate technologies inc received three separate fda 3500a report filing notifications against 3 probes involved in likely the same event as they were from the same institution, with same event date and same event description.We initiated (b)(4) for the investigation and reached out to the distributor for information pertaining to complaints from the end user as northgate technologies, inc was not aware of the malfunctions prior to the medwatch reporting.On 04jul2022, the distributor reported the three complaints to nti, against the fda 3500a reports submitted by the end user.The distributor indicated there was no health consequences or impact to patient outcome.On 01sep2022, the distributor has closed the complaint after three failed attempts requesting for product return with the end user.The distributor informed nti to close the complaint as no product return.Capa22073 was closed with assessment of available information as a physical evaluation of the product was unable to be performed.No patient death or serious injury was reported.The device history record for bsc15863 from february 2022 (mo 15863) was reviewed and the lot passed all testing.Nothing out of the ordinary was noted.The (b)(4) risk analysis was reviewed.Risk id 7.2.12(a) and (b) refers to degradation leading to particle remaining in the body that may cause blockage possibly from the tip detaching, or firing the probe past useful life may cause firing inside the polyimide sheath or probe deterioration causing a procedure delay.Product labeling indicates "single-use only" and a lifetime expiration date.Generator tracks probe life and alerts operator as the probe comes close to and when it reaches end of life.Operator's manual warns to remove all particles.The tips can be removed by minimally invasive means or the tips will pass through the patients system with no harm to the patient.Risk id 7.3.5 (d) refers to accidental mechanical damage that leads to "no spark due to damaged probe - procedure delayed".Per the operator's manual on page 2 under warnings "to avoid procedural delays and possible incomplete stone fragmentation, please have two (2) or more ehl probes available for each lithotripsy procedure." the risk of death or serious injury from the stated issue is remote.A follow up report will be submitted if further information becomes available or product is returned back to nti for evaluation.

Event Description

Event title: confidential.Describe the event or problem: patient undergoing ercp (endoscopic retrograde cholangiopancreatography) cholangioscopy with ehl (electrohydraulic lithotripsy).Four probes were used.Per attending physician: first probe broke outside of patient after use.Second probe used until it no longer worked.Third probe tip broke off.What was the original intended procedure? : ercp.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
• Type of Device: INTRA-CORPOREAL ELECTROHYDRAULIC LITHOTRIPSY (IEHL) PROBE
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES, INC; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 14851286
• MDR Text Key: 294924390
• Report Number: 14851286
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/14/2022,10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: BSC15863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic