MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Jagwire; Endoscopic Guidewire, Gastroenterology-Urology

Model Number	M00556601
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used during a colorectal stent placement procedure in the sigmoid colon performed on (b)(6) 2026.During withdrawal, the guidewire became caught within the colorectal stent and could not be withdrawn.Consequently, the guidewire could not be removed with the endoscope.The endoscope was successfully removed from the patient.The guidewire was cut at the anal verge and a portion of the guidewire remained in situ.The retained segment included not only the hydrophilic tip but also part of the core wire.According to the physician assessment, the event was attributed to a technical error during the procedure.The retained guidewire segment was subsequently removed through a surgical procedure, although the date of the surgery was unknown.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of guidewire device difficult to remove from the patient.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f19 captures the reportable event of surgical intervention.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50351124
• Report Number: 3005099803-2026-03420
• Device Sequence Number: 10256224
• Product Code: OCY
• UDI-Device Identifier: 08714729172154
• UDI-Public: (01)08714729172154(17)270305(10)33566418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00556601
• Device Catalogue Number: M00556601
• Device Lot Number: 0033566418
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 03/05/2024
• 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