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	2200-2510-B
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a4: the patient''s weight 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.Block g2: (b)(6).Block h3: the angiosculpt evo device was returned for evaluation, along with a non-philips guidewire and guide catheter.Visual inspection of the angiosculpt device found an elevated scoring element, damaged transition tubing, damaged proximal bond, lacerated rx port, and a bent hypotube near the strain relief.Additionally, a longitudinal shaft tear was observed along the length of the catheter up to the rx port but remained intact.The core wire at the distal shaft was exposed, resulting in a sharp edge of non-malleable material.Visual inspection of the non-philips guide catheter confirmed a crushed distal tip.Block h6: based on the device evaluation, some degree of force may have been applied to remove the angiosculpt while passing through the non-philips damaged guide catheter distal tip.This likely caused or contributed to the damage observed on the angiosculpt.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 to treat a moderately calcified mid circumflex artery.The angiosculpt was loaded over a 0.014¿ bmw guidewire and inserted through the 6f guidezilla guide catheter with no resistance.The angiosculpt was inflated and deflated with no issues.During removal, resistance was noted and could not be removed from the guide catheter; therefore, everything was removed as a unit.Upon removal, it was observed that the balloon and the outer shaft of the angiosculpt was sheared but remained intact.Additionally, the distal portion of the guidewire had separated and was located on the floor, and the tip of the guide catheter was damaged.Fluoroscopy confirmed that nothing was left inside the patient.A new guidezilla guide catheter, new bmw guidewire, and a nc balloon were placed to complete the procedure.However, damage was observed on the nc balloon and was replaced with another nc balloon, but the same damage was observed.The physician believes that the guide catheter got mangled on the tavr cage (corevalve) during insertion and subsequently damaged the distal tip of the guide catheter; which caused the damage to all the devices passing through.The procedure was completed with the second nc balloon.No patient injury reported.During the product return evaluation, the core wire was exposed resulting in a sharp edge of non-malleable material.This product problem is being reported due the sharp edge observed.There is a potential for harm if the malfunction were to recur.

• 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 ; 719377-8986
• MDR Report Key: 18049547
• Report Number: 3005462046-2023-00030
• Device Sequence Number: 20852222
• Product Code: NWX
• UDI-Device Identifier: 00813132026844
• UDI-Public: (01)00813132026844(11)220920(17)250920(10)G22090031
• 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
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2025
• Device Model Number: 2200-2510-B
• Device Catalogue Number: 2200-2510-B
• Device Lot Number: G22090031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 7F INTRODUCER SHEATH UNK MFG; ABBOTT: 0.014" BMW GUIDEWIRE; BOSTON SCIENTIFIC: 6F GUIDEZILLA GUIDE CATHETER
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White