EXTRACTOR PRO
Report
- Report Number
- 3005099803-2024-02356
- Event Type
- Death
- Date Received
- May 20, 2024
- Date of Event
- April 17, 2024
- Report Date
- June 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E0306 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E233605 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODE F2303 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.
H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E0306 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E233605 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODE F2303 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE DIAGNOSIS OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS USED TOGETHER WITH A SPYBITE BIOPSY FORCEPS AND AN EXTRACTOR PRO TO REMOVE THE STONES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED SEPSIS ON (B)(6) 2024, AND WAS UNDER MEDICINE CONTROL. ON (B)(6) 2024, THE PATIENT HAD SEPTIC SHOCK WHICH LED TO DEATH ON THE SAME DAY. REPORTEDLY, IT WAS UNKNOWN IF THE PATIENT HAS ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE RESULT OF THE BIOPSY WAS POSITIVE CHOLANGIOCARCINOMA. CORRECTION: IN THE PHYSICIAN'S ASSESSMENT, THE SPYSCOPE DS II, SPYBITE BIOPSY FORCEPS, AND THE EXTRACTOR PRO DID NOT CONTRIBUTE TO THE PATIENT'S SEPSIS. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 24, 2024: IT WAS REPORTED THAT A SPHINCTEROTOMY WAS PERFORMED ON THE PATIENT FROM A DIFFERENT HEALTH CARE FACILITY PRIOR TO THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING THE SPYSCOPE DS II. THE 7FR ADVANIX STENT THAT WAS IMPLANTED WAS REMOVED TO PROCEED WITH THE SPYGLASS PROCEDURE AND A 10FR/7 ADVANIX RX STENT WAS THEN PLACED AFTER TO COMPLETE THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE DIAGNOSIS OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS USED TOGETHER WITH A SPYBITE BIOPSY FORCEPS AND AN EXTRACTOR PRO TO REMOVE THE STONES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED SEPSIS ON (B)(6) 2024, AND WAS UNDER MEDICINE CONTROL. ON (B)(6) 2024, THE PATIENT HAD SEPTIC SHOCK WHICH LED TO DEATH ON THE SAME DAY. REPORTEDLY, IT WAS UNKNOWN IF THE PATIENT HAD ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE RESULT OF THE BIOPSY WAS POSITIVE FOR CHOLANGIOCARCINOMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1608432 | EXTRACTOR PRO | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| O |