MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC. PHOENIX 1.5MM X 149CM, 4F ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P15149K
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2, a4: no information available.Block b6: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the phoenix catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.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 or Problem Description
It was reported that a phoenix atherectomy system was used in a therapeutic peripheral procedure in a moderately calcified and fibrous lesion.During removal, the rotational cutter head separated from the shaft within the introducer sheath in the left iliac artery.A snare was used to retrieve the cutter head, and no patient injury reported.This adverse event and product problem is being submitted due to the cutter head separation requiring intervention (snare).

• Brand Name: PHOENIX 1.5MM X 149CM, 4F ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC.; 1530 o brien drive; suite a; menlo park CA 94025
• Manufacturer (Section G): VOLCANO ATHEROMED, INC.; 1530 o brien drive; suite a; menlo park CA 94025
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 17865202
• Report Number: 3008847191-2023-00002
• Device Sequence Number: 14998325
• Product Code: MCW
• UDI-Device Identifier: 00845225003173
• UDI-Public: (01)00845225003173(17)250731(10)11012213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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: 07/31/2025
• Device Model Number: P15149K
• Device Catalogue Number: P15149K
• Device Lot Number: 11012213
• 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: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: CSI: 0.014" VIPERWIRE.; TERUMO: 6F INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White