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	04/02/2026
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: address listed reflects the specification developer.Block g2: foreign- germany blocks h3 & h6: the phoenix catheter was not returned for evaluation; thus, no 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 atherectomy catheter was used for a therapeutic peripheral procedure in a cto at the distal popliteal.During use, the catheter was advanced over a phoenix guidewire to the site of the occlusion, which performed well by fully reopening the vessel.However, at the distal end of the occlusion, the guidewire rotated despite being secured to the torquer, and the catheter drill head bored into the guidewire and became jammed; therefore, removed as a system.Upon removal, it was noted that a small piece of the guidewire had separated (mdr 9681477-2026-00052); unable to retrieve due to the area not being accessible and was not relevant to the foot's blood supply.The procedure was completed with a drug coated balloon with no patient injury reported.This product problem is being submitted because the phoenix catheter and guidewire were removed as a system.There is potential for harm if it were to recur.

• 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: danielle bullock ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4125
• MDR Report Key: 24865586
• Report Number: 3007284006-2026-00134
• Device Sequence Number: 21091647
• Product Code: MCW
• UDI-Device Identifier: 00845225002725
• UDI-Public: (01)00845225002725(17)261130(10)3120390020
• 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,Followup
• Report Date (Section B): 07/13/2026

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: 3120390020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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: PHILIPS VOLCANO: 0.014 PHOENIX GUIDEWIRE; TERUMO: 5F RADIFOCUS INTRODUCER SHEATH
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White