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

Model Number	H7493926912120
Medical Device Problem Codes	Difficult to Advance (2920); 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	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon could not reach the lesion site, and the catheter was found to be kinked after withdrawn.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified middle segment of left anterior descending diagonal branch.A 1.2mm x 12mm fg threader monorail was selected for coronary artery angiography (cag) and percutaneous transluminal coronary angioplasty (ptca).During the procedure, it was noted that the balloon could not reach the lesion site, and the catheter was found to be kinked after withdrawn.The procedure was completed with a different device.No patient complications were reported and the patient was stable after the procedure.However, device analysis revealed a complete circumferential tear in the balloon.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination identified multiple kinks along the hypotube.No kinks or damages were identified along the polymer shaft.A microscopic examination of the distal extrusion identified that the inner lumen was flattened at 12cm from distal tip.A detailed microscopic examination of the balloon material identified a complete circumferential tear in the balloon.The tear was located at 1.4cm from the tip of the device.A microscopic examination of the tip section found no damage.A microscopic examination of the markerband found no damage.Due to the flattening that was evident in the inner wire lumen at 12cm from the tip, it was not possible to load a 0.014inch size guidewire through the inner wire lumen.

• 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: 22161730
• Report Number: 2124215-2025-34745
• Device Sequence Number: 7266182
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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 Expiration Date: 01/09/2026
• Device Model Number: H7493926912120
• Device Catalogue Number: H7493926912120
• Device Lot Number: 0033179029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 55 KG