MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 2.4MM X 130CM 7F PRE-DEFLECTING ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PD24130K
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a phoenix atherectomy catheter was used in a therapeutic peripheral procedure.The phoenix catheter was delivered over a 0.014" phoenix guidewire with no issues.However, during removal, the catheter got stuck on the guidewire, and both were removed as a system.Visible under fluoroscopy, the tip of the guidewire (mdr 9681477-2025-00026) had separated and was stented to the vessel wall.Since the atherectomy procedure was not sufficient as expected due to the severely calcified lesion, the patient was brought back five days later for bypass.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.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2, a4, a5: date of birth, weight, and ethnicity- not available from facility.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.Blocks e1 & g2: country is germany.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.

• Brand Name: PHOENIX 2.4MM X 130CM 7F PRE-DEFLECTING 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: 21706870
• Report Number: 3007284006-2025-00053
• Device Sequence Number: 4539698
• Product Code: MCW
• UDI-Device Identifier: 00845225003197
• UDI-Public: (01)00845225003197(17)261231(10)02202401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: PD24130K
• Device Catalogue Number: PD24130K
• Device Lot Number: 02202401
• 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: 03/13/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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: TERUMO: 7F CROSS OVER INTRODUCER SHEATH.; VOLCANO: 0.014 PHOENIX GUIDEWIRE.
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White