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 Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's ethnicity and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Attempts to obtain the information has not been successful.The angiosculpt device was returned for evaluation.Visual inspection found a distal bond peel with one leaflet lifted, but remained intact to the device.During functional testing, a laboratory asahi sion blue 0.014" coated guide wire was activated with saline and inserted through the distal tip and through the device, with slight resistance.After balloon inflation/deflation, with slight resistance the guide wire was removed from the device.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.
Event or Problem Description
The angiosculpt device was used to treat the proximal rca and upon removal, the balloon got pinned to the wire and had to be removed as a unit.The balloon was inflated 3 times to 18 atm (rbp is 16 atm).No issues observed or reported during delivery.The lesion was rewired without complications to complete the procedure.No patient injury reported.During the returned device analysis, a distal bond peel was observed.This adverse event is being submitted because the angiosculpt and guidewire were removed as a unit.Placement of a new guide wire was necessary to complete the procedure.In addition, this product problem is being submitted because the distal bond peeled, potential for harm if it were to recur.
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: 12733990
• Report Number: 3005462046-2021-00061
• Device Sequence Number: 14587220
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: 00813132026899
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: 2200-3015-B
• Device Catalogue Number: 2200-3015-B
• Device Lot Number: G21030006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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; BOSTON SCIENTIFIC: AL GUIDE CATHETER SIZE UNK; TERUMO: 6F INTRODUCER SHEATH
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 74 KG