MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Block b3: according to the literature article, patients with choledocholithiasis confirmed by computed tomography or magnetic resonance imaging from january 2016 to july 2018 were enrolled in the research study.Exact procedure dates are unknown.Block d4, h4: the device upns or lot numbers were not provided in the literature article.Therefore, the manufacture and expiration dates are unknown.Block e1: initial reporter facility name: (b)(6).Block g2: literature source: journal article: long, et al."analysis of clinical effects of intubation and sphincterotomy with wire-guided incision knife plus balloon dilatation in the treatment of choledocholithiasis: a randomized controlled trial." surg laparosc endosc percutan tech; volume 32, number 5, october 2022.Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf impact code f23 captures the reportable event of unexpected medical intervention for patient treatment required.

Event Description

Boston scientific became aware of an event involving autotome sphincterotome and guidewire devices through the article, analysis of clinical effects of intubation and sphincterotomy with wire-guided incision knife plus balloon dilatation in the treatment of choledocholithiasis: a randomized controlled trial, by jianwu long, phd, et al.Per the article, the study was designed to investigate the clinical effects of intubation and sphincterotomy with wire-guided incision knife plus balloon dilatation (isbd) in the treatment of choledocholithiasis.A total of 270 patients with choledocholithiasis confirmed by computed tomography or magnetic resonance imaging from january 2016 to july 2018 were enrolled in the study and randomly divided into 3 groups: isbd group, endoscopic sphincterotomy (est) group, and endoscopic sphincterotomy plus balloon dilation (esbd) group.The clinical effects, complications, and inflammation indexes of the 3 groups were compared and evaluated.All procedures were performed using a video duodenoscope and cannulation of the bile duct was conducted with a 20 mm cut wire sphincterotome with a 0.035 inch guidewire.There were no significant differences in sex and age among the 3 groups.No significant differences were found in average diameter of common bile duct, total bilirubin, diameter, and number of gallstones in patients of the 3 groups.The clinical results found there was a significant difference in the total intubation time and total operation time of the 3 groups.The total stone removal rate of the 3 groups were all 100%.This study revealed the same total stone clearance rates for est, esbd, and isbd.However, there is a higher first stone clearance rate of isbd than est and esbd, indicating the potential of isbd in reducing hospital stay, costs, and repeat complications.Postoperative acute pancreatitis was observed in 3 patients in the est group, 4 patients in the esbd group and 1 patient in the isbd group.The cases were accompanied by mild pancreatitis and the symptoms recovered quickly after treatment.Cholangitis occurred in 2 patients in the est group and 2 patients in the esbd group.Hemorrhage occurred in 25 patients in the est group and 2 patients in the esbd group.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17798683
• MDR Text Key: 324036700
• Report Number: 3005099803-2023-05085
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention