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	2200-3020-B
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt catheter was used in a coronary procedure in the distal circumflex artery.During removal, difficulty was encountered when removing from the guidewire; therefore, the angiosculpt and guidewire were removed as a system.Upon removal, the scoring element was unraveled, but remained intact to the catheter.The procedure was completed with a non-angiosculpt catheter.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 h3: the angiosculpt catheter was returned intact to an 0.014" non-philips guidewire.Visual inspection found a damaged scoring element that detached from the intermediate bond, and pulled distally, over the distal tip.Additionally, the intermediate bond and transition tubing were damaged.During functional testing, an attempt was made to remove the catheter from the guidewire, but was unsuccessful.The catheter working length measured approx.143 cm, which is 1 cm over the specification of 136-142 cm, indicating the guide wire lumen was stretched.Block h6: based on the device analysis, a probable root cause may be due to the damaged guidewire lumen (stretched) preventing the catheter from being removed separately from the guidewire.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 ; 510933-4541
• MDR Report Key: 22109170
• Report Number: 3005462046-2025-00022
• Device Sequence Number: 8140162
• Product Code: NWX
• UDI-Device Identifier: 00813132026905
• UDI-Public: (01)00813132026905(11)250219(17)280219(10)G25020011
• 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): 05/29/2025

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: 2200-3020-B
• Device Catalogue Number: 2200-3020-B
• Device Lot Number: G25020011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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: ASAHI: 0.014" SION BLUE GUIDE WIRE; MEDTRONIC: LAUNCHER GUIDE CATHETER, UNK SIZE; TERUMO: 6F GLIDE INTRODUCER SHEATH
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian