MAUDE Adverse Event Report: Philips Image Guided Therapy Corporation AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating; Catheter, PTCA, Cutting/Scoring

Model Number	2200-3015-B
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction

• Brand Name: AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating
• Common Device Name: Catheter, PTCA, Cutting/Scoring
• Manufacturer (Section D): Philips Image Guided Therapy Corporation; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): Philips Image Guided Therapy Corporation; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; +1(510)933-4541
• MDR Report Key: 50596812
• Report Number: 3005462046-2026-00059
• Device Sequence Number: 18680952
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: (01)00813132026899(11)251120(17)281120(10)0303639808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 2200-3015-B
• Device Catalogue Number: 2200-3015-B
• Device Lot Number: 0303639808
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 217 LB
• Patient Race: Asian