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

Model Number 2200-3510-B

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

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.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign- (b)(6).The angiosculpt device was infectious and discarded 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 as a unit.In addition, retained device component is listed as an adverse effect of the procedure.

Event Description

The angiosculpt device was used to treat a severely tortuous and severely calcified proximal rca.During advancement, resistance was noted likely due to the vessel tortuosity.The balloon was inflated and deflated 3 times under rbp with no issues.Upon removal, resistance was encountered and fluoroscopy confirmed a shaft separation at the exit port within the guide catheter.The separated portion was removed by inflating a balloon which remained inflated to pull the separated section.The procedure was completed with the suspect angiosculpt device with no patient injury reported.This adverse event and product problem is being submitted due to the additional intervention required to remove the separated portion of the device from the patient.

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
• Type of Device: 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: 12863296
• MDR Text Key: 283089306
• Report Number: 3005462046-2021-00071
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132026929
• UDI-Public: 00813132026929
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: 2200-3510-B
• Device Catalogue Number: 2200-3510-B
• Device Lot Number: G21030018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASAHI: 0.014" SION BLUE GUIDEWIRE; MEDTRONIC: 6F LAUNCHER GUIDE CATHETER; TERUMO: INTRODUCER SHEATH SIZE UNK
• Patient Outcome(s): Required Intervention