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

Model Number	P15149K
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a2-a4: not available from facility.Block b6: not available from facility.Block c: not applicable for this device.Blocks d4 & h4: the lot number was not provided; thus, the following information is unknown: unique id, expiration date, and manufacture date.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.Block h3: the phoenix catheter was infectious/discarded by the facility; thus, no product investigation was performed.Block h6: the phoenix catheter would not move smoothly over the abbott guidewire, potentially due to the severe calcification, requiring much force to go over the guidewire.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 for a peripheral procedure in a severely calcified distal dorsalis pedis artery (dpa).During the second introduction of the catheter, it would not move smoothly over the abbott guidewire, potentially due to the calcification, requiring much force to go over the guidewire.When the catheter and guidewire was being removed, it was noticed that the guidewire was seemingly cut by the catheter, even though the distance between the tips of the catheter and guidewire were sufficient.Angio confirmed nothing else was retained in the patient, other than the guidewire distal tip.The pulse in the patient's foot was measured and obtained; procedure was completed.This adverse event is being submitted conservatively because the phoenix catheter was being used concomitantly when the abbott guidewire separated; retained in patient.

• 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: danielle bullock ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4125
• MDR Report Key: 25023529
• Report Number: 3007284006-2026-00166
• Device Sequence Number: 15694249
• Product Code: MCW
• UDI-Device Identifier: 00845225003173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P15149K
• Device Catalogue Number: P15149K
• Device Lot Number: 02062408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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: ABBOTT: 0.014 HI-TORQUE GUIDEWIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown
• Patient Race: White