MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3515-B
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Details obtained from the france competent authority on 10jul2023: during dilatation of the circumflex artery, the angiosculpt balloon was inflated, but did not deflate and was occlusive in the artery.Additional information obtained from the philips representative on 20jul2023: the angiosculpt device was used to treat a moderately fibrous proximal circumflex artery.The balloon was inflated to 10 atm and deflated with no issues.During removal, difficulty was noted due to the old stent and angulation.A parallel wire and another balloon were used to remove the device.The procedure was completed with a non-angiosculpt device.No patient injury was reported.This adverse event and product problem is being submitted due to the retraction problem, requiring additional intervention for removal.
Additional Manufacturer Narrative
Block a: the patient''s dob or age at time of event, gender, 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- france / other- competent authority.Block h3: the angiosculpt device was not returned for evaluation by the facility, thus no returned product investigation was performed.Block h6: based on the complaint details, it is likely that the patient condition (stent and angulation) caused or contributed to the retraction problem.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
• 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: 17375402
• Report Number: 3005462046-2023-00025
• Device Sequence Number: 3715553
• Product Code: NWX
• UDI-Device Identifier: 00813132026936
• UDI-Public: (01)00813132026936(11)230301(17)260301(10)G23030001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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 Expiration Date: 03/01/2026
• Device Model Number: 2200-3515-B
• Device Catalogue Number: 2200-3515-B
• Device Lot Number: G23030001
• Was Device Available for Evaluation?: No
• 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: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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 LAUNCHER GUIDE CATHETER; TERUMO: 0.014" RUNTHROUGH GUIDEWIRE; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown