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U.S. Department of Health and Human Services

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

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NORTHGATE TECHNOLOGIES, INC AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE Back to Search Results
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). ".
 
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Brand NameAUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
Type of DeviceINTRA-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 Key12475857
MDR Text Key271526352
Report Number0001450997-2021-00006
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
PMA/PMN Number
K130368
Number of Events Reported1
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
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72-00322-0
Device Catalogue NumberM00546620
Device Lot NumberBSC15166
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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