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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, gender, sex, weight, ethnicity, and race are 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 catheter was returned in two pieces.Visual inspection found the catheter separated at the intermediate shaft.All parts of the catheter were accounted for with no missing pieces observed.During functional testing, a laboratory 0.014 inch guidewire was inserted through the distal tip, able to pass through the device, and out through the exit port with no resistance noted.Block h6: based on the complaint details, the shaft separation likely occurred due to the force applied by the user.Per the ifu, retained device component is listed as a possible adverse effects of the procedure.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 proximal lad artery.During delivery and removal, resistance was encountered.While removing from the patient, some degree of force was applied, but the shaft separated.The separated portion was removed successfully with a snare.Imaging confirmed that no fragments were left inside the patient.The procedure was completed with the suspect device with no patient injury reported.This adverse event and product problem is being submitted due to the shaft separation requiring medical intervention for removal.

• 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: 21152505
• Report Number: 3005462046-2025-00001
• Device Sequence Number: 21141267
• Product Code: NWX
• UDI-Device Identifier: 00813132026905
• UDI-Public: (01)00813132026905(11)241031(17)271031(10)G24100017
• 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): 01/14/2025

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: 2200-3020-B
• Device Catalogue Number: 2200-3020-B
• Device Lot Number: G24100017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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: CORDIS: BRITE TIP INTRODUCER SHEATH, UNK SIZE; MEDTRONIC: 8F EBU GUIDE CATHETER; TERUMO: 0.014" RUNTHROUGH GUIDEWIRE
• Patient Sex: Unknown