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	2200-3515-B
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: the patient's date of birth is unknown.This information was not available from the facility.Block b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Blocks h3/h6: the angiosculpt device was not returned by the facility, thus no product investigation was performed.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
The angiosculpt device was used for a therapeutic coronary procedure in a severely calcified rca.During use, the balloon was inflated to 14 atm, and after several inflations, the balloon was unable to deflate, despite multiple standard techniques (negative pressure, alternate inflators, saline inflation).An attempt was made to puncture the needle intravascularly, but ultimately, the shaft was cut, and a guideliner was advanced over the shaft.Rotaglide was injected for lubrication, and the catheter was successfully removed via guideliner-assisted extraction without loss of wire position.The procedure was competed with no patient injury reported.This adverse event and product problem is being submitted due to balloon unable to deflate, requiring intervention.
Additional Manufacturer Narrative
Block h3: the angiosculpt catheter was returned in two pieces, which aligns with the reported complaint that the shaft was intentionally cut (between strain relief and proximal shaft).Additionally, the balloon and scoring element were missing and not returned.Visual inspection found a damaged/stretched shaft, and separated core wire; exposing sharp edges but remained intact to the device.No functional testing was performed due to the nature of the returned device.Block h6: the root cause of the deflation issue could not be determined since the balloon was missing; therefore, the cause could not be established.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: 24745874
• Report Number: 3005462046-2026-00012
• Device Sequence Number: 18497428
• Product Code: NWX
• UDI-Device Identifier: 00813132026936
• UDI-Public: (01)00813132026936(11)250324(17)280324(10)G25030018
• 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,Followup
• Report Date (Section B): 04/30/2026

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: 2200-3515-B
• Device Catalogue Number: 2200-3515-B
• Device Lot Number: G25030018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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: 5F FR4 GUIDE CATHETER, UNK MFG; 5F JL4 GUIDE CATHETER, UNK MFG; 6F AL 0.75 GUIDE CATHETER, UNK MFG; ASAHI: CONFIANZA GUIDEWIRE, UNK SIZE; ASAHI: CORSAIR MICROCATHETER, UNK SIZE; ASAHI: MIRACLE GUIDEWIRE, UNK SIZE; TERUMO: 6F SLENDER INTRODUCER SHEATH; TERUMO: RUNTHROUGH GUIDEWIRE, UNK SIZE
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White