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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 Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Hepatitis (1897)
Event Date 02/11/2022
Event Type  Injury  
Event Description
On 21feb2022, northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation ". After less than 24 hours the subject had an episode of cholangitis. The adverse event is serious since the outcome will result in prolonged hospitalization. The relationship with our procedure is probable. A cholangiography was performed on (b)(6) 2022, but no residual lithiasis was observed. The biliary drainage was replaced. The subject was treated with antibiotic therapy and is fine". There was no alleged device malfunction during the ehl procedure.
 
Manufacturer Narrative
On 21feb2022, northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation ". After less than 24 hours the subject had an episode of cholangitis. The adverse event is serious since the outcome will result in prolonged hospitalization. The relationship with our procedure is probable. A cholangiography was performed on (b)(6) 2022, but no residual lithiasis was observed. The biliary drainage was replaced. The subject was treated with antibiotic therapy and is fine". There was no alleged device malfunction during the ehl procedure. There are 2 suspect devices used during the incident from different lots and are being reported separately. On 23feb2022 requested additional information from the distributor on the procedure and the suspect devices. As of 16mar2022, we have not received any additional information despite multiple requests from the end user. Capa (b)(4) was initiated to investigate the event with available information from the end user. The suspect device has been requested to be returned for investigation. The probes have not been returned for evaluation. The device history record for bsc15242 from april 2021 (mo 15242) was reviewed and the lot passed all testing. Currently there is no known or suspected malfunction noted with the suspect device given that the distributor complaint coding on the device was "no known device problem" and a review of the device history record of the lot that was involved in the incident. A follow up report will be filed with any additional information and findings when it becomes available.
 
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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 Key13793864
MDR Text Key287354811
Report Number0001450997-2022-00003
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K130368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number72-00322-0
Device Catalogue NumberM00546620
Device Lot NumberBSC15242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/17/2022 Patient Sequence Number: 1
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