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

Model Number	M00557641
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a cystogastrostomy procedure was performed on (b)(6) 2026.During the procedure, a blue tube was retrieved from the patient's stomach.Further comparison to device packaging determined that the blue tube was from the jagwire used during the initial procedure on 01 jun 2026.A photo of a similar device was provided and indicated the blue tube from the device that should be removed and discarded before use.It was reported that the blue tube was the one that fell inside the patient; however, per the instructions for use (ifu), to remove the guidewire from the hoop, first remove and discard the small blue tube from the inner diameter of the clear hoop.Advance wire until the wire is exposed out of the outer diameter of the hoop.A follow-up ct scan is planned in 4-6 weeks to reassess the condition prior to stent removal.It was reported that the patient's current condition is clinically well.
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of an additional device required.Block h11: investigation results the jagwire device was not returned for analysis as the device was disposed; therefore, a technical analysis could not be performed.However, a media analysis was performed on the photo provided by the complainant.The photo revealed the section of the device where the blue tube is located, no damages where identified.No other problems with the device were noted.According to the media analysis performed, the photo revealed the section of the device where the blue tube is located, no damages where identified.However, there is no objective evidence or descriptive conditions to establish the cause of the reported event.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of additional device required was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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 ; 9145716918
• MDR Report Key: 25829204
• Report Number: 3005099803-2026-02825
• Device Sequence Number: 21421611
• Product Code: OCY
• UDI-Device Identifier: 08714729296676
• UDI-Public: (01)08714729296676(17)290316(10)38856622
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00557641
• Device Catalogue Number: M00557641
• Device Lot Number: 0038856622
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 03/17/2026
• 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