MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRA JAGWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Cholangitis (4821)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of six devices mentioned in the literature article.Refer to manufacturer reports # 3005099803-2024-05666, 3005099803-2024-05669, 3005099803-2024-05804, 3005099803-2024-05805 and 3005099803-2024-05806 for the associated device information.Boston scientific became aware of events involving jagwire guidewires, autotome rx sphincterotomes, pull type sphincterotomes, microknife needle knife papillotomes, and rx locking devices through the article, comparison of physician-controlled maneuver and assistant-controlled maneuver during endoscopic retrograde cholangiopancreatography, by min je sung, et al.Per the article, between january 2015 and december 2016, patients underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure in which physician-controlled wire-guided cannulation (pcwgc) and/or assistant-controlled wire-guided cannulation (acwgc) cannulation techniques were used.In cases where pcwgc was utilized, the following occurred: pancreatitis, bleeding, perforation, cholangitis.In cases where acwgc was utilized, the following occurred: pancreatitis, bleeding, perforation.Please see the referenced article for full details.
Additional Manufacturer Narrative
Block a2: patients exact ages are unknown; however, it was reported in the literature article that all patients were over the age of 20.Block b3: the exact date of event was not reported.The retrospective study date january 1, 2015, is used for the estimated date of event between january 2015 and december 2016.Block d4, h4: the literature article did not provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6), reported here as the name exceeded character limit for designated field.Block g2: literature source journal article: sung m, et al."comparison of physician-controlled maneuver and assistant-controlled maneuver during endoscopic retrograde cholangiopancreatography." yonsei med j 2024; https://doi.Org/10.3349/ymj.2023.0115 block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e1109 captures the reportable event of cholangitis.

• Brand Name: HYDRA JAGWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-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: 20670722
• Report Number: 3005099803-2024-05668
• Device Sequence Number: 8502737
• Product Code: EZB
• UDI-Device Identifier: 08714729648437
• UDI-Public: 08714729648437
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: M00556001
• Device Catalogue Number: 5600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown