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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt catheter was used for a therapeutic coronary procedure in the lad.During use, the catheter got stuck, and had to pull together with the guidewire and guide catheter.The procedure was completed with a regular balloon.No patient injury reported.During device analysis, a detached scoring element was observed.This product problem is being submitted due to the removal as a system and detached scoring element; potential for harm.
Additional Manufacturer Narrative
Block a2-a6: the patient's dob or age at time of event, gender, sex, weight, ethnicity, and race are unknown.This information was not available from the facility.Blocks b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block h3: the angiosculpt catheter was returned without the concomitant devices (guidewire, guide catheter).Visual inspection found the scoring element detached from the intermediate bond and pulled distally over the distal tip but remained intact to the device.The distal bond was damaged, and the distal shaft and core wire were kinked.The balloon appeared deflated; however, the balloon did not appear to rewrap.During functional testing, a laboratory 0.014" guidewire was inserted through the distal tip but was unable to pass through the exit port due to occlusion.The laboratory guide wire was then inserted through the proximal end of the guide wire lumen; however, still unable to pass through.A flattened guidewire lumen was noted near the proximal end.Block h6: the root cause of the device getting stuck could not be established.However, based on the device analysis, the damaged scoring element may be due to a balloon rewrap issue (affecting balloon profile), and during removal, may have damaged the intermediate bond; resulting in the scoring element being pulled distally with some degree of force.Additionally, the device history record (dhr) was reviewed, and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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: 50876933
• Report Number: 3005462046-2026-00064
• Device Sequence Number: 13447585
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: (01)00813132026899(11)260109(17)290109(10)0303673748
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 0303673748
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F Introducer Sheath, Unk Mfg; Medtronic: EBU Guide Catheter, Unk Size; Terumo: Runthrough Guidewire, Unk Size
• Patient Sex: Unknown