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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h3: the phoenix catheter was returned for evaluation.Visual inspection found a wire protruding from the catheter distal tip; likely the stent that was pulled out together with the catheter during use.Additionally, the catheter gear would not rotate freely, as it returned back to its original position, and the flex capacitor had collapsed.During functional testing, the knob was able to rotate with no issues.Further, a wire was loaded through the proximal and distal end of the catheter, but was unable to pass through the entire lumen.Block h6: the probable cause of the reported failure is due use error and patient condition.Per the complaint details, the phoenix catheter was turned on in what was thought to be the peroneal, but was mistakenly in the tibial peroneal trunk where an undersized stent was present.The ifu sates that the safety and effectiveness of the phoenix atherectomy system has not been established in patients with in-stent restenosis at the peripheral vascular site.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.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks b6 & b7: no information available.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 h3 & h6: the phoenix catheter was returned; however, device evaluation is pending.A supplemental report will be submitted once evaluation is completed.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 moderately calcified peripheral procedure.Prior to using the catheter in the peroneal, ivus was performed in the posterior tibial where it was noticed that an undersized stent was in the vessel, thus decided not to use the catheter in that area.The phoenix catheter was turned on in what was thought to be the peroneal, but was mistakenly in the tibial peroneal trunk, when a weird sound was noted.The battery pack was flipped but nothing was happening.The catheter was removed over the guidewire, but the catheter clipped the end of the stent and pulled it out.No stent replacement was needed since the vessel looked good.The procedure was completed with a new catheter with no patient injury reported.This product problem is being submitted because the phoenix catheter and existing stent 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: danielle bullock ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4125
• MDR Report Key: 23536286
• Report Number: 3007284006-2025-00236
• Device Sequence Number: 21338806
• Product Code: MCW
• UDI-Device Identifier: 00845225002725
• UDI-Public: (01)00845225002725(17)260131(10)3590390020
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 01/31/2026
• Device Model Number: P18149K
• Device Catalogue Number: P18149K
• Device Lot Number: 3590390020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2025
• 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: ASAHI: 0.014 MONGO GUIDEWIRE; TERUMO: DESTINATION INTRODUCER SHEATH, SIZE UNK
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White