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	07/24/2026
Type of Reportable Event	Malfunction

• 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: ayse kharodawala ; 9965 federal drive; colorado springs, CO 80921 ; +1(858)720-4063
• MDR Report Key: 50124397
• Report Number: 3007284006-2026-00411
• Device Sequence Number: 10478406
• Product Code: MCW
• UDI-Device Identifier: 00845225002725
• UDI-Public: (01)00845225002725(17)261031(10)3110390250
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: P18149K
• Device Catalogue Number: P18149K
• Device Lot Number: 3110390250
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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
• Patient Sex: Male
• Patient Race: White