MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 2.2MM X 130CM 6F PRE-DEFLECTED ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PD22130K
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2 & a4 : date of birth and weight not available from the 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 (contact information): address listed reflects the specification developer.Block h3: the phoenix catheter and handle were returned, but without the guidewire.Visual inspection of the catheter found a collapsed flex capacitor and a stalled cutter, indicating the device encountered severe friction during use.During functional testing, a 0.014" laboratory guidewire was inserted but unable to advance due to debris in the shaft.For the handle, this worked as intended as it ran at 12300 rpm.Block h6: the probable cause of the catheter locking onto the guidewire could be due to incorrect prep or flushing.However, the cause could not be established since the guidewire was not returned with the phoenix catheter.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 therapeutic peripheral procedure in a moderately calcified distal sfa.During removal, the handle battery died causing the catheter to lock onto the guidewire, and the entire system was removed as a unit.The procedure was completed with angioplasty with no patient injury reported.Outside of patient, the guidewire was aggressively removed from the catheter, and the guidewire was bent and kinked.This product problem is being submitted because the phoenix catheter and concomitant device were removed as a system; potential for harm.

• Brand Name: PHOENIX 2.2MM X 130CM 6F PRE-DEFLECTED ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 158/1 moo 5, bangkadi ind. pk; tiwanon rd, tambol bangkadi; amphur muang pathum thani 12000 ; TH 12000
• Manufacturer Contact: danielle bullock ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4125
• MDR Report Key: 22014719
• Report Number: 3007284006-2025-00095
• Device Sequence Number: 15426983
• Product Code: MCW
• UDI-Device Identifier: 00845225003586
• UDI-Public: (01)00845225003586(11)240703(17)270430(10)4790390290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: PD22130K
• Device Catalogue Number: PD22130K
• Device Lot Number: 4790390290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White