EXPECT
Report
- Report Number
- 3005099803-2023-03187
- Event Type
- Injury
- Date Received
- June 21, 2023
- Date of Event
- May 1, 2023
- Report Date
- August 25, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ODG
- PMA / PMN Number
- K110030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.
BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT.
BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THAT WERE REPORTED DURING THE 105TH JAPAN GASTROINTESTINAL ENDOSCOPY SOCIETY (JGES) RELATED TO CASES OF LOWER BILE DUCT DRAINAGE UNDER ENDOSCOPIC ULTRASOUND (EUS) USING 22-GAUGE EXPECT EUS NEEDLE. ACCORDING TO THE LITERATURE, BETWEEN MARCH 2021 AND JULY 2022, 22-GUAGE EXPECT EUS NEEDLES WERE USED DURING THE INDUCTION PHASE OF EUS-GUIDED LOWER BILE DUCT DRAINAGE PROCEDURES. AN EXPECT NEEDLE AND A FIELDER 18 (OLYMPUS) GUIDEWIRE WERE USED IN ALL CASES DURING THE STUDY PERIOD. IN ADDITION, METAL STENTS WERE USED FOR ANTEGRADE STENTING (AS) AND PLASTIC STENTS WERE USED FOR HEPATICOGASTROSTOMY (HGS)/ HEPATICOJEJUNOSTOMY (HJS). CLINICAL SUCCESS WAS DEFINED AS A 50% OR GREATER REDUCTION IN BILIRUBIN IN JAUNDICE PATIENTS AND IMPROVEMENT IN CHOLANGITIS IN CHOLANGITIS PATIENTS. TWENTY-ONE CASES, WHICH INCLUDED 11 MALES AND 10 FEMALES, UNDERWENT THE PROCEDURE. PATIENT AGE RANGED FROM 40-YEARS-OLD TO 88-YEARS-OLD, WITH 71-YEARS-OLD AS THE MEDIAN AGE. OF THE 21 PATIENTS, THERE WERE 7 CASES OF PANCREATIC CANCER, 6 CASES OF GASTRIC CANCER, 2 CASES OF GALLBLADDER CANCER, 2 CASES OF CHOLANGIOCARCINOMA, AND 4 CASES NOT MENTIONED. THE PLANNED PROCEDURES WERE 6 HGS PROCEDURES, 13 HGS/HJS+AS, 1 HGS+BRIDGING, AND 1 HGS+BRIDGING+AS. TARGET BILE DUCT PUNCTURE WAS SUCCESSFUL IN ALL 21 CASES. DOUBLE GUIDE WIRE TECHNIQUE WAS PERFORMED IN 8 CASES. PROGRESSIVE BIOPSY WAS PERFORMED IN 4 CASES. ONE CASE SCHEDULED FOR HGS+AS UNDERWENT AS ALONE DUE TO STENT FAILURE, AND ONE CASE SCHEDULED FOR HGS+BRIDGING UNDERWENT HGS ALONE DUE TO FAILURE TO SELECT THE TARGET BILE DUCT. CLINICAL SUCCESS WAS ACHIEVED IN 20 PATIENTS (95.2%). ONE CASE WITH UNSUCCESSFUL BRIDGING DID NOT ACHIEVE A REDUCTION IN YELLOWING. THIS REPORT CAPTURES 6 ADVERSE EVENTS OBSERVED IN 6 PATIENTS (28.6%). THESE INCLUDE 2 CASES OF INTRA-ABDOMINAL EMPHYSEMA, 1 CASE OF PANCREATITIS, 1 CASE OF CHOLANGITIS REQUIRING STENT REPLACEMENT, 1 CASE OF CHOLECYSTITIS REQUIRING PERCUTANEOUS TRANSHEPATIC GALLBLADDER ASPIRATION (PTGBA), AND 1 CASE OF GUIDE WIRE INTRAPORTAL INSERTION. IT IS UNKNOWN WHAT CAUSED THESE INCIDENTAL CASES. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THAT WERE REPORTED DURING THE 105TH JAPAN GASTROINTESTINAL ENDOSCOPY SOCIETY (JGES) RELATED TO CASES OF LOWER BILE DUCT DRAINAGE UNDER ENDOSCOPIC ULTRASOUND (EUS) USING 22-GAUGE EXPECT EUS NEEDLE. ACCORDING TO THE LITERATURE, BETWEEN MARCH 2021 AND JULY 2022, 22-GUAGE EXPECT EUS NEEDLES WERE USED DURING THE INDUCTION PHASE OF EUS-GUIDED LOWER BILE DUCT DRAINAGE PROCEDURES. AN EXPECT NEEDLE AND A FIELDER 18 (OLYMPUS) GUIDEWIRE WERE USED IN ALL CASES DURING THE STUDY PERIOD. IN ADDITION, METAL STENTS WERE USED FOR ANTEGRADE STENTING (AS) AND PLASTIC STENTS WERE USED FOR HEPATICOGASTROSTOMY (HGS)/ HEPATICOJEJUNOSTOMY (HJS). CLINICAL SUCCESS WAS DEFINED AS A 50% OR GREATER REDUCTION IN BILIRUBIN IN JAUNDICE PATIENTS AND IMPROVEMENT IN CHOLANGITIS IN CHOLANGITIS PATIENTS. TWENTY-ONE CASES, WHICH INCLUDED 11 MALES AND 10 FEMALES, UNDERWENT THE PROCEDURE. PATIENT AGE RANGED FROM 40-YEARS-OLD TO 88-YEARS-OLD, WITH 71-YEARS-OLD AS THE MEDIAN AGE. OF THE 21 PATIENTS, THERE WERE 7 CASES OF PANCREATIC CANCER, 6 CASES OF GASTRIC CANCER, 2 CASES OF GALLBLADDER CANCER, 2 CASES OF CHOLANGIOCARCINOMA, AND 4 CASES NOT MENTIONED. THE PLANNED PROCEDURES WERE 6 HGS PROCEDURES, 13 HGS/HJS+AS, 1 HGS+BRIDGING, AND 1 HGS+BRIDGING+AS. TARGET BILE DUCT PUNCTURE WAS SUCCESSFUL IN ALL 21 CASES. DOUBLE GUIDE WIRE TECHNIQUE WAS PERFORMED IN 8 CASES. PROGRESSIVE BIOPSY WAS PERFORMED IN 4 CASES. ONE CASE SCHEDULED FOR HGS+AS UNDERWENT AS ALONE DUE TO STENT FAILURE, AND ONE CASE SCHEDULED FOR HGS+BRIDGING UNDERWENT HGS ALONE DUE TO FAILURE TO SELECT THE TARGET BILE DUCT. CLINICAL SUCCESS WAS ACHIEVED IN 20 PATIENTS (95.2%). ONE CASE WITH UNSUCCESSFUL BRIDGING DID NOT ACHIEVE A REDUCTION IN YELLOWING. THIS REPORT CAPTURES 6 ADVERSE EVENTS OBSERVED IN 6 PATIENTS (28.6%). THESE INCLUDE 2 CASES OF INTRA-ABDOMINAL EMPHYSEMA, 1 CASE OF PANCREATITIS, 1 CASE OF CHOLANGITIS REQUIRING STENT REPLACEMENT, 1 CASE OF CHOLECYSTITIS REQUIRING PERCUTANEOUS TRANSHEPATIC GALLBLADDER ASPIRATION (PTGBA), AND 1 CASE OF GUIDE WIRE INTRAPORTAL INSERTION. IT IS UNKNOWN WHAT CAUSED THESE INCIDENTAL CASES. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640423 | EXPECT | ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY | ODG | BOSTON SCIENTIFIC CORPORATION | M00550010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |