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

Model Number	H74938931040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified segment around the axillary artery in the arm.A pt2 moderate support 300 cm str guidewire was selected for use.However, during the procedure, the tip of the pt2 guidewire broke after being inserted into the vein.The device was removed using a very small retrieval tool to extract it out, and the procedure was completed using another brand of guidewire.No patient complications were reported, and the patient fully recovered.
Additional Manufacturer Narrative
A pt2 moderate support 300 cm str guidewire was returned for analysis.A visual and microscopic inspection revealed a bent distal tip and that a portion of the tip was detached.The distal tip was not returned for analysis.A dimensional inspection revealed the total length of the returned device was 117.9 inches.The length specification of the pt2 guidewire is 117.9+/-0.1 inches.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified segment around the axillary artery in the arm.A pt2 moderate support 300 cm str guidewire was selected for use.However, during the procedure, the tip of the pt2 guidewire broke after being inserted into the vein.The device was removed using a very small retrieval tool to extract it out, and the procedure was completed using another brand of guidewire.No patient complications were reported, and the patient fully recovered.

• 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: 21480583
• Report Number: 2124215-2025-09940
• Device Sequence Number: 20969165
• Product Code: DQX
• UDI-Device Identifier: 08714729471226
• UDI-Public: 08714729471226
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/28/2025

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: 07/30/2026
• Device Model Number: H74938931040
• Device Catalogue Number: H74938931040
• Device Lot Number: 0034539520
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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