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

Model Number	2777
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detached, and embolism occurred.The patient presented with coronary stenosis.The 70% stenosed lesion was located in the non-tortuous and non-calcified proximal left circumflex artery (lcx).A pt2 guidewire was selected for use.During the procedure, the tip of the guidewire became dislodged upon retraction, resulting in an embolic complication.The detached tip remained in the obtuse marginal (om) branch, and no retrieval was attempted due to the vessel's small.The procedure was completed using a non-boston scientific guidewire.There were no further patient complications, the patient was successfully treated for stenosis and was discharged from the hospital.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the pt2 device was returned for analysis.Visual and microscopic inspection revealed no signs of detachment at the distal tip, which was returned intact for analysis.However, the distal tip was noted to be bent.Dimensional inspection was conducted to verify the total length of the guidewire against the specifications.The specified length was 72.6 inches with an allowable tolerance of plus or minus 0.1 inches., resulting in an upper limit of 72.7 inches and a lower limit of 72.5 inches.The returned guidewire measured exactly 72.6 inches, confirming that it was received in complete condition for analysis.The reported 'distal tip detachment of device or device component' was not confirmed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that tip detached, and embolism occurred.The patient presented with coronary stenosis.The 70% stenosed lesion was located in the non-tortuous and non-calcified proximal left circumflex artery (lcx).A pt2 guidewire was selected for use.During the procedure, the tip of the guidewire became dislodged upon retraction, resulting in an embolic complication.The detached tip remained in the obtuse marginal (om) branch, and no retrieval was attempted due to the vessel's small.The procedure was completed using a non-boston scientific guidewire.There were no further patient complications, the patient was successfully treated for stenosis and was discharged from the hospital.

• 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: 22965389
• Report Number: 2124215-2025-62177
• Device Sequence Number: 9141740
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: (01)08714729471196(17)270602(10)36660266
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0036660266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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