MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 1.5MM X 149CM 4F ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P15149K
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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.Not applicable for this device.Blocks d1 & g (contact information): address listed reflects the specification developer.The phoenix catheter was not returned, thus no returned product investigation was performed.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 severely fibrous proximal popliteal lesion.The catheter was delivered over a non-philips guidewire, and advanced to the lesion and turned on.After less than a minute, the catheter was turned off and attempted to remove, but got stuck on the guidewire and was removed as a system.The procedure was completed with angioplasty.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 1.5MM X 149CM 4F 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: 22983914
• Report Number: 3007284006-2025-00166
• Device Sequence Number: 21067407
• Product Code: MCW
• UDI-Device Identifier: 00845225003531
• UDI-Public: (01)00845225003531(11)241022(17)271031(10)4110390120
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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 Model Number: P15149K
• Device Catalogue Number: P15149K
• Device Lot Number: 4110390120
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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: 0.014 VIPER WIRE GUIDE WIRE; BIOTRONIK: 5F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White