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

Model Number 72-00322-0

Device Problems Device Emits Odor (1425); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Northgate technologies received notification from customer boston scientific on (b)(6) 2018 of an alleged event in that it was reported that "while using the ehl probe, it was noticed that the wire on tip of the probe was expose and the protective coating seem to be frayed, this was after one thousand shots in the common bile duct".And "there was a smell of smoke coming from the scope".Northgate technologies received two (2) probes on november 1, 2018 of parts 72-00322-0, autolith touch bsc ds probe 1.9fr (french) 375cm, lot bsc13281 under rma# (b)(4), and rma# (b)(4) (complaints (b)(4) respectively).The autlith touch lithotripsy system is a bipolar electrosurgical modality which creates a spark between the center-conductor and tip of the probe in normal physiological saline to effect a cavitation bubble to hydraulically fracture calculi in the billiary system.The 1.9 french probes are designed to last between 600 and 1200 shots, and the autolith touch generator provides an alert at 1100 shots, and ceases to allow operation beyond 1230 shots.The operating manual contains the warning, ".Regardless of the "replace probe" message, stop using immediately and use a new probe: firing (or arcing) behind the tip, ejection of tip or insulation material, arcing along the wires or inside /outside of the connector".Both probes were visually inspected.The probe under (b)(4) did not show any signs of degradation - the tip was in-tact, and epoxy was present with the center-conductor at the tip.The probe under (b)(4) was also visually inspected and it was determined "complaint verified, no tip.Based on the pictures, there is evidence of charring near the tip area which is caused by the probe firing behind the tip and/or after the tip has fallen off".This probe was inspected under a microscope where it was determined that the tip was missing, and the polyimide tubing showed limited signs of burn/charring.This is consistent with an end-of life failure of the probe where the probe is fired passed the indicated end-of-life.In this circumstance, the center-conductor disintegrates to the end of the probe tip, and dislodges the probe tip.Continued firing of the probe can begin to burn or char the polyimide tubing of the probe.This erosion of the polyimide poses no additional risk to the patients beyond the odor.The customer statement that the observation of "wire on the tip of the probe was exposed" is consistent with the statement of "this was after one thousand shots int he common bile duct".The probe under (b)(4) fired normally for 80 shots.No further issues were noted with this probe.A device history record review was conducted where it was determined that "a review of mo bsc13281 was performed and nothing out of the ordinary was found.The mo pass all tests on april 23, 2018".All probes are fired for 30-shots at the end of the production line, and lots are sampled for firing to the end of life, after-which they undergo a pull-test at the tip to ensure tip integrity at the end of life.Lot bsc13481 passed all in-process and final quality checks.The lot passed with an average shot count of 1201 shots, and a average tip pull force of 6.74 lbs.Additionally the risk analysis was reviewed (document (b)(4)) for the tip coming off, where it was determined, "with respect to the tip falling off in section 7.2.12, "particle remaining in body that may cause blockage, possibly from distal tip detaching", the mitigation of that is that, "the tips can be removed by minimally invasive means or the tips will pass through the patients system with no harm to the patient".This report is being filed for the smell of smoke.

Event Description

It was reported that the ehl generator was set to high / 30 settings for a large bile duct stone case.The first ehl probe worked well and no complaints.While using the ehl probe, it was noticed that the wire on tip of the probe was expose and the protective coating seem to be frayed, this was after one thousand shots in the common bile duct.The second probe was removed after noticing the exposed wire.They subsequently placed another ehl probe down the same channel.Once they started firing shots and there was a smell of smoke coming from the scope.Based on the second probe having an exposed wire, the doctor did not feel faze in continuing to use the third probe when it started to smell.

• 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: 8121956
• MDR Text Key: 130654018
• Report Number: 0001450997-2018-00003
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72-00322-0
• Device Catalogue Number: 72-00322-0
• Device Lot Number: BSC13281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1