MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred.A pt2 guidewire was selected for percutaneous coronary intervention (pci) at the left anterior descending (lad) artery.Upon opening the package, a break in the guidewire shaft was observed.The procedure was successfully completed with another device.No patient complications occurred, and the patient made a full recovery.
Event or Problem Description
It was reported that guidewire detachment occurred.A pt2 guidewire was selected for percutaneous coronary intervention (pci) at the left anterior descending (lad) artery.Upon opening the package, a break in the guidewire shaft was observed.The procedure was successfully completed with another device.No patient complications occurred, and the patient made a full recovery.
Additional Manufacturer Narrative
Device history review: a device history record (dhr) review was could not be performed for the pt2 as no batch number was reported.Device technical analysis: the device was not returned for analysis since it was disposed; therefore, a technical analysis could not be performed on the device.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review performed for the pt2 device confirmed that the event of 'guidewire detachment of device or device component' is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of 'unable to exclude device problem' following a review of the reported event details and available information.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event.Improper handling, device manipulation or not following the correct instructions during the procedure, alongside the anatomical conditions of the patient, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24489598
• Report Number: 2124215-2026-11446
• Device Sequence Number: 20084489
• Product Code: DQX
• UDI-Device Identifier: 08714729471110
• UDI-Public: (01)08714729471110
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K030617
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2777
• Device Catalogue Number: 2777
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Patient Sex: Unknown