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

Model Number 2200-3015-B

Device Problem Material Separation (1562)

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

Event Date 01/12/2023

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 medical history is unknown.This information was not available from the facility.The angiosculpt device was returned in two pieces.Visual inspection found a separation at the distal shaft, distal to the rx port.The separation at the distal shaft exposed a sharp tip of the core wire; however the core wire is a malleable material.All parts of the device were accounted for with no missing pieces observed.Per the ifu, retained device component is listed as a possible adverse effects of the procedure.The angiosculpt device is indicated for use in the coronary lesion; however, the device was used off-label in a peripheral procedure.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 Description

The angiosculpt coronary device was used off-label in a peripheral procedure to treat the proximal right perineal artery.Upon removal, resistance was noted and the device separated at the intermediate shaft.Under fluoroscopy, the separated portion was located in the aorta just before the femoral bifurcation.An attempt to snare the separated portion was made, but unable to bring it into the 6fr sheath.The sheath was upsized to a 16fr and was able to remove it successfully from the patient.A new balloon and stent was used to complete the procedure with no patient complications reported.The patient was discharged home the following day.This adverse event and product problem is being submitted due to the shaft separation requiring medical intervention for removal.

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 ; 510673-223
• MDR Report Key: 16354644
• MDR Text Key: 309305668
• Report Number: 3005462046-2023-00005
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132026899
• UDI-Public: 00813132026899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2200-3015-B
• Device Catalogue Number: 2200-3015-B
• Device Lot Number: G22060015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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: BOSTON SCIENTIFIC: 0.014" CHOICE PT GUIDEWIRE.; TERUMO: 6F DESTINATION GUIDE/SHEATH.
• Patient Outcome(s): Required Intervention