MAUDE Adverse Event Report: Spectranetics Corporation AngioSculpt OTW PTA Scoring Balloon Catheter; Catheter, Percutaneous, Cutting/Scoring

Model Number	2076-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction

• Brand Name: AngioSculpt OTW PTA Scoring Balloon Catheter
• Common Device Name: Catheter, Percutaneous, Cutting/Scoring
• Manufacturer (Section D): Spectranetics Corporation; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): Spectranetics Corporation; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; +1(858)720-4037
• MDR Report Key: 50791917
• Report Number: 3005462046-2026-00061
• Device Sequence Number: 18522806
• Product Code: PNO
• UDI-Device Identifier: 00813132021399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 2076-6040
• Device Catalogue Number: 2076-6040
• Device Lot Number: 0303672561
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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