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); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2/a3b/a4/a5: the patient's dob or age at time of event, gender, weight, and ethnicity are unknown.This information was not available from the facility.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block g2: foreign- portugal.Blocks h3/h6: the angiosculpt catheter was retained by the facility, thus no product investigation was performed.However, based on the complaint details, the catheter got stuck on the calcified lesion, which likely required some degree of force for removal, resulting in the separation.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.
Event or Problem Description
The angiosculpt device was used in a therapeutic coronary procedure for a moderately calcified proximal lad.During use, the scoring balloon became stuck in the vessel and was unable to move.Several approaches were attempted to remove; however, the catheter shaft separated.The proximal portion was removed from the patient, and the distal portion was retained by inserting a new guidewire to pass through the balloon, and stents were placed to crush to the vessel wall.The patient is in stable condition and under observation.This adverse event and product problem is being submitted due to device separation, requiring intervention but retained in patient.
Additional Manufacturer Narrative
Block e1: facility name and address was corrected from (b)(6) to (b)(6).Note: the initial mdr allowed a four digit zip code ((b)(6)); however, for the supplemental mdr, it will not allow a passed submission when (b)(6) is entered in block e1; therefore, it was intentionally left blank.

• 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 ; 510933-4541
• MDR Report Key: 24260584
• Report Number: 3005462046-2026-00006
• Device Sequence Number: 9766753
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: (01)00813132026899(11)250711(17)10)G25070013
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: G25070013
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO: 6F GUIDE CATHETER; TERUMO: 6F RADIFOCUS INTRODUCER SHEATH; TERUMO: RUNTHROUGH GUIDE WIRE, UNK SIZE
• Patient Sex: Female
• Patient Race: White