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	2200-3510-B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An angiosculpt device was used to treat a severely calcified lesion in the proximal lad.During use, resistance was encountered and the distal portion got dislodged from the shaft.A balloon and guideline were used to retrieve the separated portion.Imaging confirmed that no device fragments were retained in the patient.The procedure was completed with a nc balloon with no patient injury reported.This product problem and adverse event is being submitted due to shaft separation, requiring additional intervention.
Additional Manufacturer Narrative
Block a2: the patient's dob is unknown.This information was not available from the facility.Block 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 returned in two pieces.The distal section includes the distal tip, distal bond, balloon, scoring element, intermediate bond, transition tubing, distal shaft, rx port, and a portion of the intermediate shaft; measuring approx.30 cm in length.The proximal section includes a portion of the intermediate shaft, core wire, hypotube, strain relief, and hub; measuring approximately 114 cm in length.Visual inspection found a necked distal shaft and a damaged intermediate bond.At the location of the separation, the core wire was exposed, resulting in a sharp edge observed.The overall catheter length (144 cm) is above the expected working length (136-142 cm), due to the necked distal shaft.Block h6: the probable cause of the shaft separation may be due to the resistance encountered, requiring some degree of force to remove from the severely calcified lesion.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.

• 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: 22441481
• Report Number: 3005462046-2025-00029
• Device Sequence Number: 7473340
• Product Code: NWX
• UDI-Device Identifier: 00813132026929
• UDI-Public: (01)00813132026929(11)250403(17)280403(10)G25040006
• 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): 07/08/2025

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: 2200-3510-B
• Device Catalogue Number: 2200-3510-B
• Device Lot Number: G25040006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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: MEDTRONIC: 6F EBU GUIDE CATHETER.; TERUMO: 6F BRITETIP INTRODUCER SHEATH.; TERUMO: RUNTHROUGH GUIDE WIRE, UNK SIZE.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White