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	2200-3010-B
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks a2/a3b: the patient's dob or age at time of event and gender are unknown.This information was not available from the facility.Blocks b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Block h3: the angiosculpt device was returned inserted through a 6f non-philips guide catheter.Visual inspection found a damaged scoring element that was pulled over the distal tip.The proximal scoring element rings detached from the intermediate bond but remained intact to the device.Additionally, the distal tip was bent, intermediate shaft was kinked, and the hub was missing (cut off by user).During functional testing, an attempt was made to retract the device through the guide catheter but was not possible due to the damaged scoring element profile.Therefore, the device was advanced in the proximal direction and was able to be removed.Further inspection found the transition tubing had separated but was contained within the distal shaft.Block h6: the complaint details indicate that the angiosculpt device got caught on an existing stent.Based on the device evaluation, it is likely that some degree of force was applied during removal, resulting in the damage observed.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.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
An angiosculpt device was used in a coronary isr procedure.During use, the balloon got stuck inside the existing stent.For removal, the hub was cut off, and then an additional guidewire and nc balloon were placed/inflated adjacent to where the balloon was stuck.The angiosculpt device was able to be removed and upon removal, it was noted that the scoring element was bent.Imaging confirmed that no device fragments were retained in the patient.The procedure was completed with no patient injury reported.This product problem and adverse event is being submitted due to device entrapment, requiring additional intervention.

• 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
• MDR Report Key: 21536869
• Report Number: 3005462046-2025-00008
• Device Sequence Number: 7642657
• Product Code: NWX
• UDI-Device Identifier: 00813132026882
• UDI-Public: (01)00813132026882(11)241024(17)271024(10)G24100010
• 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): 03/06/2025

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: 2200-3010-B
• Device Catalogue Number: 2200-3010-B
• Device Lot Number: G24100010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: 6F GUIDE CATHETER, UNK MFG; TERUMO: RUNTHROUGH GUIDEWIRE, UNK SIZE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White