MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number M00550010

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pancreatitis (4481); Insufficient Information (4580)

Event Date 05/01/2023

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: EXPECT
• Type of Device: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17175245
• MDR Text Key: 317639625
• Report Number: 3005099803-2023-03187
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00550010
• Device Catalogue Number: 5001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention