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	2200-2510-B
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Blocks h3/h6: the angiosculpt device was not returned by the facility, thus no returned product investigation was performed.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 catheter was used to treat a moderately calcified lesion in the mid lad.During removal, resistance was noted, and the scoring element may have got caught on an existing isr stent.With some degree of force applied, the catheter and the non-philips guidewire were able to be removed as a system.The procedure was completed with no patient injury reported.This product problem is being submitted due to removal as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Block b5/h2: this event is no longer reportable based on new information received on 08apr2025.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
Additional information confirmed that the angiosculpt device was removed by itself.Therefore, this is no longer reportable for removal as a system.There is no potential for harm with recurrence.

• 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: 21415947
• Report Number: 3005462046-2025-00005
• Device Sequence Number: 9208853
• Product Code: NWX
• UDI-Device Identifier: 00813132026844
• UDI-Public: (01)00813132026844(11)240909(17)270909(10)G24090005
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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 Model Number: 2200-2510-B
• Device Catalogue Number: 2200-2510-B
• Device Lot Number: G24090005
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI: PROWATER GUIDEWIRE, UNK SIZE; MEDTRONIC: 5F EBU 3.5 GUIDE CATHETER; TERUMO: 5F INTRODUCER SHEATH
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White