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

Model Number	2781
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target stenosed lesion was located in the moderately tortuous and calcified in anterior tibial artery (ata).A 300cm moderate support, j-tip (pt2 5pk) guidewire was selected for vascular intervention below the knee (btk).However, during the procedure, the guidewire tip bent and was broken and difficult to recover from vessel.The tip was caught and removed using a snare tool, and the procedure was completed using new guidewire.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.During product analysis it was observed that the distal end of the guidewire was detached from the rest of the guidewire, and the distal tip was bent.Therefore, the reported device detachment was confirmed.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target stenosed lesion was located in the moderately tortuous and calcified in anterior tibial artery (ata).A 300cm moderate support, j-tip (pt2 5pk) guidewire was selected for vascular intervention below the knee (btk).However, during the procedure, the guidewire tip bent and was broken and difficult to recover from vessel.The tip was caught and removed using a snare tool, and the procedure was completed using new guidewire.No patient complications were reported.

• 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: 21985340
• Report Number: 2124215-2025-29615
• Device Sequence Number: 8553579
• Product Code: DQX
• UDI-Device Identifier: 08714729471257
• UDI-Public: (01)08714729471257(17)260516(10)34049229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 05/16/2026
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0034049229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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