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

Model Number	2200-3015-B
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient''s dob or age at time of event and weight are unknown.This information was not available from the facility.Patient information regarding medical history is unknown.This information was not available from the facility.Report source: foreign- (b)(6).The angiosculpt device has not been returned by the facility, thus no returned product investigation was performed.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system.
Event or Problem Description
The angiosculpt device was used in a moderately calcified proximal rca.After multiple inflation/deflation at 16 atm, the angiosculpt got stuck on the non-manufacturer''s guidewire at the distal rca, thus were removed as a unit.The lesion was rewired and the procedure was completed with a new angiosculpt device.No patient injury reported.This adverse event is being reported because the angiosculpt got stuck on a non-manufacturer''s guide wire and removed as a unit.Placement of a new guide wire was necessary to complete the procedure.
Additional Manufacturer Narrative
Block h3: two angiosculpt devices were returned to the manufacturer since it was unknown which device malfunctioned.Visual inspection found no unusual characteristics of both devices.During functional testing, a laboratory asahi sion blue 0.014" coated guidewire was activated with saline and inserted through the laboratory 6f introducer sheath.Then, one at a time an angiosculpt device was loaded over the guidewire through the distal tip and passed through the guidewire lumen with no resistance.Using an indeflator filled with water, the balloon was inflated to 16 atm (rbp) and deflated with no issues.Both devices were able to be removed from the guidewire with no resistance noted.Block h6: based on the device analysis, both devices performed as intended and no problem was detected.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
Blocks d1/ g1: manufacturer name and site name were updated from spectranetics to philips image guided therapy corporation to match the information on the product label.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: ana tan ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 14417568
• Report Number: 3005462046-2022-00019
• Device Sequence Number: 5552376
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: 00813132026899
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2024
• Device Model Number: 2200-3015-B
• Device Catalogue Number: 2200-3015-B
• Device Lot Number: G21090040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 06/01/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/24/2022; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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: 0.014" SION BLUE GUIDEWIRE.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian