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

Model Number	M00556581
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)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to jagwires that were used in the retrospective study.Boston scientific became aware of events involving captivator ii snares, interject needles, jagwires and resolution clips through the article "the usefulness of traction-assisted endoscopic papillectomy for ampullary early tumors" by xie jiao et al.Per article, between january 2010 and august 2022, study of 173 patients suffering ampullary tumors underwent endoscopic papillectomy procedures.Two techniques were used: traction assisted, and non-traction assisted methods.The following occurred with the study patients: pancreatitis, cholangitis, perforations, intraoperative bleeding that required endoscopic hemostasis and blood transfusion.Please see the reference article for full details.
Additional Manufacturer Narrative
Block b3: the exact date of event was not reported.The retrospective study date january 1, 2010, is used for the estimated date of event between january 2010 and august 2022.Block h4: the suspect device lot number was not reported.Therefore, the manufacture and expiration dates are unknown.Block e1: initial reporter address 1: (b)(6); reported here as the address exceeded character limit for the designated field.Block g2: literature source: journal article: xie, j, et al."the usefulness of traction-assisted endoscopic papillectomy for ampullary early tumors" scandinavian journal of gastroenterology 2023; https://doi.Org/10.1080/00365521.2023.2289353.Block h6: imdrf patient code e1021 captures the reportable event of a pancreatitis.Imdrf patient code e0506 captures the reportable event of intraprocedural/delayed bleeding.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2202 captures the reportable event of endoscopic hemostasis.Imdrf impact code f12 captures the reportable event of conservative medical treatment.

• Brand Name: JAGWIRE
• Common Device Name: 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: 21035624
• Report Number: 3005099803-2024-06549
• Device Sequence Number: 20981081
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141820
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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: M00556581
• Device Catalogue Number: 5658
• 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: 12/03/2024
• Initial Report FDA Received Date: 12/30/2024
• 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: Required Intervention
• Patient Sex: Unknown