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	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt catheter was used in a coronary procedure.During use, the balloon was inflated for approx.20 with no issues.However, the balloon was unable to deflate; therefore, the catheter was then slowly removed from the patient.Upon removal, the balloon was slightly inflated and the scoring element was damaged.The scoring element detached from one end of the balloon but remained intact on the opposite end.No patient injury reported.This product problem is being submitted due to the balloon unable to deflate; potential for harm.
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.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block g2: foreign- united kingdom.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 catheter was used in a coronary procedure.During use, the balloon was inflated for approx.20 minutes with no issues, and up to 18 atm for the last inflation.The balloon was deflated on fluoroscopy but could not be removed despite traction and countertraction.The balloon was reinflated to 6 atm, but was now unable to deflate.Negative suction was applied to deflate the balloon, saline was administered to decrease viscosity, and passed a wire into the balloon lumen, but none worked.Another wire and a 2.0 balloon was advanced alongside the first half of the inflated balloon, gently pulled back, and tried to puncture the balloon with the stiff end of the wire, but was not possible to remove.Therefore, everything was pulled back to the radial sheath, and was removed in one piece.Upon removal, the balloon was slightly inflated and the scoring element was damaged.The scoring element detached from one end of the balloon but remained intact on the opposite end.No patient injury reported.This adverse event and product problem is being submitted due to the balloon unable to deflate; requiring additional intervention for removal.
Additional Manufacturer Narrative
Blocks a2/a3a/a4/a6: patient's dob, age at time of event, sex, weight, and race are now available.Blocks b1/b5: updated to include the additional complaint details received.Block b7: other relevant history, including preexisting medical conditions are now available.Block d10: concomitant medical products (guide wire, introducer sheath, and guide catheter) brand names are now available.Block h6: additional intervention was performed to retrieve the catheter.Heic code f23 (unexpected medical intervention) replaces f26 (no health consequences or impact).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.
Additional Manufacturer Narrative
Block h3: the angiosculpt catheter was returned intact to an 0.014" non-philips guidewire and sheath.Visual inspection of the catheter found the scoring element detached from the intermediate bond with no sharp edges observed.Additionally, the distal shaft was necked and stretched, measuring approx.28 cm in length, which is 4 cm over the specification of 22-24 cm.No damage was observed on the guidewire and sheath.During functional testing, the returned guidewire was able to be removed, then inserted back through the catheter distal tip, and advanced with no issues.Using an indeflator filled with green color dye water, the balloon was unable to inflate, which was likely due to the damaged distal shaft.Therefore, at the location of the damage, the distal shaft was cut off, and a tuohy borst was used to secure inflation.The balloon was pressurized and inflated/deflated with no issues.Block h6: based on the device analysis, the probable cause of the catheter unable to be removed from the guidewire may be due to the damaged scoring element preventing the catheter from being removed separately.Further, the probable cause of the balloon deflation issue is likely due to the damaged distal shaft, preventing the balloon from being able to deflate.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: 23361181
• Report Number: 3005462046-2025-00039
• Device Sequence Number: 8863879
• 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: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/30/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/12/2026
• 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: ASAHI: SION BLUE GUIDE WIRE, UNK SIZE; MEDTRONIC: EBU 3.5 GUIDE CATHETER, UNK SIZE; MERIT: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: White