MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THREADER?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493926912120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft broke.The target lesion was located in the coronary artery.A 1.2mm x 12mm fg threader monorail was selected for percutaneous coronary intervention (pci).During insertion, the balloon shaft broke.The device was removed from the patient in one piece and the procedure was completed.There were no patient complications and the patient fully recovered.
Event or Problem Description
It was reported that the shaft broke.The target lesion was located in the coronary artery.A 1.2mm x 12mm fg threader monorail was selected for percutaneous coronary intervention (pci).During insertion, the balloon shaft broke.The device was removed from the patient in one piece and the procedure was completed.There were no patient complications and the patient fully recovered.

• Brand Name: THREADER?
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23934345
• Report Number: 2124215-2025-93942
• Device Sequence Number: 13164600
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: (01)08714729848127(17)270709(10)36924745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: H7493926912120
• Device Catalogue Number: H7493926912120
• Device Lot Number: 0036924745
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 07/09/2025
• 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
• Patient Sex: Unknown