AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
Report
- Report Number
- 0001450997-2023-00002
- Event Type
- Death
- Date Received
- May 24, 2023
- Date of Event
- January 26, 2023
- Report Date
- April 24, 2023
- Manufacturer
- NORTHGATE TECHNOLOGIES INC.
- Product Code
- FFK
- UDI-DI
- 00817183020448
- PMA / PMN Number
- K130368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE IS NO PRODUCT MALFUNCTION REPORTED OR SUSPECTED IN THE PROCEDURE THAT PRECEDED THIS EVENT. THE SERIAL NUMBER OF THE CAPITAL EQUIPMENT USED IN THIS EVENT IS UNKNOWN. DUE TO THE FACT THAT PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE LENGTH OF TIME FROM THE EVENT DATE AND THE DATE NOTIFIED TO THE MANUFACTURER IT IS BELIEVED THAT THE SINGLE USE DEVICE USED IN THIS CASE WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT# 16431 FROM AUGUST 2022 (MO 16431) WAS REVIEWED AND THE LOT PASSED ALL TESTING. NOTHING OUT OF THE ORDINARY WAS NOTED. AS INDICATED IN THE COMPLAINT DESCRIPTION BY THE INITIAL COMPLAINANT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO KNOW MALFUNCTION OR COMPLICATION DURING THE PROCEDURE EXECUTION. THE RISK OF EXCESSIVE BLEEDING WHICH COULD LEAD TO DEATH IS A KNOWN RISK OF THIS TYPE OF PROCEDURE AND IS NOTED WITHIN THE DEVICE RISK ANALYSIS AND CLINICAL EVALUATION REPORT WHICH INCORPORATES POST-MARKET INFORMATION. THE (B)(4) RISK ANALYSIS WAS REVIEWED. (B)(4) REFERS TO THE RISK OF PATIENT INJURY FROM BLEEDING. THE RISK LEVEL SCORE IS 8 WHICH CORRESPONDS TO A RISK THAT REQUIRES ACTION AND IS THEREFORE A RESIDUAL RISK. THE MANUAL CONTAINS THE FOLLOWING WARNINGS "IMPROPER USE OF THE EHL PROBE COULD RESULT IN VESSEL PERFORATION FOLLOWED BY BLEEDING AND POSSIBLE INFECTION. OTHER COMPLICATIONS SUCH AS VESSEL STRICTURES RESULTING FROM EDEMA AND OCCLUSIONS CREATED BY STONE DEBRIS ARE ALSO POTENTIAL COMPLICATIONS OF EHL.", "THIS DEVICE SHOULD BE OPERATED ONLY BY OR UNDER THE DIRECT SUPERVISION OF A PHYSICIAN EXPERIENCED IN ELECTROHYDRAULIC LITHOTRIPTER PROCEDURES. THE USER SHOULD BE THOROUGHLY FAMILIAR WITH THE OPERATION OF THIS DEVICE PRIOR TO USE.", AND "DO NOT PRESS THE DISTAL TIP OF THE PROBE AGAINST TISSUE. TISSUE DAMAGE, INCLUDING PERFORATION OR THERMAL INJURY CAN RESULT." THE OCCURRENCE RATE OF BLEEDING IS RATED AS A 4 OCCASIONAL. A 6 YEAR COMPLAINT ANALYSIS WAS PERFORMED IN (B)(4) AND NOTED 1 REPORT FOR THIS DEVICE FAMILY AND EXCESSIVE BLEEDING. (B)(4). IF FURTHER INFORMATION WAS TO BECOME AVAILABLE OR PRODUCT RETURNED FROM THE FIELD FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED AT THAT TIME. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT AND POST MARKET SURVEILLANCE SYSTEMS TO ASSURE PATIENT SAFETY.
ON 24APR2023 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC, "PER CNF, IT WAS REPORTED THAT: EHL WAS PERFORMED USING AN OLYMPUS BILIARY SPECULUM. THE PROCEDURE ITSELF WAS SUCCESSFUL, BUT THE PATIENT'S CONDITION CHANGED SUDDENLY AND HE DIED LATER THAT DAY. THE PATIENT'S CONDITION CHANGED SUDDENLY DUE TO BLEEDING FROM THE LIVER OBLITERATION THAT OCCURRED THE DAY AFTER THE PROCEDURE." "AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM" "EVENT OCCURRED (B)(6) 2023, PROCEDURE OCCURRED (B)(6) 2023". ADDITIONAL QUESTIONS WERE FOLLOWED UP WITH THE DISTRIBUTOR. ON 15MAY2023, THE DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION THAT THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND THAT THE PATIENT WAS A POST-LIVER TRANSPLANT PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1185961 | AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC | INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE | FFK | NORTHGATE TECHNOLOGIES INC. | 72-00322-0 | 16431 | 00817183020448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |