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	2200-2515-B
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks a4: the patient's weight is 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 device was infectious and discarded by the facility, thus no returned product investigation was performed.Block h6: per the ifu, "proceed cautiously when using the angiosculpt evo scoring balloon catheter in a freshly deployed bare metal or drug eluting stent.The angiosculpt catheter has not been tested for post-dilation of stents or lesions distal to freshly deployed stents in clinical studies." 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 catheter was used to treat a severely calcified distal lad.Prior to use of the angiosculpt, a stent was place in between two existing stents (distal and proximal lad).A xience drug-eluting stent (des) was deployed in the mid lad to bridge the gap, and then the angiosculpt was inflated at the distal stent.The angiosculpt deflated with no issues; however, during pullback, the angiosculpt got caught on the xience, causing it to crumble in a ball.A couple techniques were made to attempt removal of both the angiosculpt and xience but were unsuccessful.The angiosculpt shaft was cut and the patient was transferred to surgery.A bypass to the lad was performed to save the vessel, but the angiosculpt and xience remained in the patient.The patient was doing well and in recovery.Five days later, the patient's blood pressure dropped suddenly and did not recover.Per philips clinical assessment, it is suspected that the cause of death was related to complications of the bypass surgery.This adverse event and product problem is being submitted due to device entrapment, requiring intervention but retained in patient.

• 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: 21890388
• Report Number: 3005462046-2025-00016
• Device Sequence Number: 20929486
• Product Code: NWX
• UDI-Device Identifier: 00813132026851
• UDI-Public: (01)00813132026851(11)241122(17)271122(10)G24110018
• 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): 04/23/2025

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: 2200-2515-B
• Device Catalogue Number: 2200-2515-B
• Device Lot Number: G24110018
• 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: 04/09/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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: MEDTRONIC: 7F INTRODUCER SHEATH; TERUMO: RUNTHROUGH GUIDE WIRE, UNK SIZE; UNK MFG AND SIZE: GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American