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

Model Number	P15149K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks a2 & a3: patient information available.Block b: updated to capture new information received.Block e4: updated from unk to no.Block h6: it was confirmed that the device was discarded and that the 1.5 mm phoenix catheter was used in a 1.2 mm vessel.The ifu warns: do not operate the phoenix atherectomy system in vessels smaller than the indicated size as perforations, dissections or injury may occur.-updated type of investigation b17 (device not returned) to b18 (device discarded) -updated investigation findings: c20 (no findings available) to c23 (usage problem identified) -updated investigation conclusions d14 (no problem detected) to d1101 (failure to follow instructions), added d12 (known inherent risk of device) all other codes in the initial mdr remain applicable.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 (1.5 mm) was used in a peripheral procedure.During use, angiographic run showed extravasation of contrast in the peroneal artery, requiring a balloon to treat the perforation.Further information states the target vessel was thought to be 1.9 mm; however, it was confirmed to be smaller at 1.2 mm.Per philips clinical assessment, the use of an oversized catheter likely contributed to the perforation.This adverse event is being submitted because a perforation occurred, requiring additional intervention.There was no alleged malfunction with the phoenix catheter.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2 (dob)-a6: not available from facility.Blocks b6 & b7: 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 e1 & g2: country is australia.Blocks h3 & h6: the phoenix catheter was not returned to the manufacturer 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.
Event or Problem Description
It was reported that a phoenix catheter (1.5 mm) was used in a peripheral procedure.During use, angiographic run showed extravasation of contrast, but it is unknown how the perforation was treated.Further information states that the vessel may have been undersized for the selected 1.5 mm phoenix catheter.This adverse event is being submitted because a perforation occurred, requiring additional intervention.There was no alleged malfunction with the phoenix catheter.

• 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: 21727069
• Report Number: 3007284006-2025-00057
• Device Sequence Number: 3928762
• Product Code: MCW
• UDI-Device Identifier: 00845225003173
• UDI-Public: (01)00845225003173(17)260531(10)11302327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Expiration Date: 05/31/2026
• Device Model Number: P15149K
• Device Catalogue Number: P15149K
• Device Lot Number: 11302327
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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: UNK MFG AND SIZE: INTRODUCER SHEATH.; VOLCANO: 0.014 PHOENIX GUIDEWIRE.
• Patient Age: 77 YR
• Patient Sex: Female