MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 1.8MM X 149CM 5F ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P18149K
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Block d4: serial # not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks d1 & g (contact information): address listed reflects the specification developer.Blocks h3 & h6: the phoenix catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7, h9 & h10: 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 catheter was used in a therapeutic peripheral procedure in a slightly calcified proximal sfa.During removal, the catheter got stuck on a non-philips guidewire, and both were removed as a system.The procedure was completed with an angioplasty balloon with no patient injury reported.This product problem is being submitted because the phoenix catheter and concomitant device were removed as a system; potential for harm.

• Brand Name: PHOENIX 1.8MM X 149CM 5F ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: diana melliza galvez ; 9965 federal drive; colorado springs, CO 80921 ; 510933-4541
• MDR Report Key: 22821705
• Report Number: 3007284006-2025-00159
• Device Sequence Number: 13199095
• Product Code: MCW
• UDI-Device Identifier: 00845225002725
• UDI-Public: (01)00845225002725(17)260630(10)3100390270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: P18149K
• Device Catalogue Number: P18149K
• Device Lot Number: 3100390270
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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: ABBOTT: .014 SPARTACORE GUIDE WIRE; BIOTRONIK: 5F INTRODUCER SHEATH; KMP: GUIDE CATHETER, UNK SIZE
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White