MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 2.4MM X 130CM 7F PRE-DEFLECTED 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	07/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a3b & a4: not available from facility.Block b6: 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 australia.Block h3: the phoenix catheter was not returned, thus no product investigation was performed.Block h6: based on the complaint details, the catheter got caught on a stent strut within the patient.Blocks h7 & h9: 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 atherectomy catheter was used for a peripheral procedure in the mid sfa.During use, the catheter got caught on a stent strut and unable to remove the catheter.An angioplasty balloon was advanced just below where the catheter was stuck, and the stent dislodged from the catheter.The catheter was withdrawn from the patient with no damage observed to the device or the stent.The procedure was finalized with no further complications and no patient injury.This adverse event and product problem is being submitted due to entrapment, requiring intervention.

• Brand Name: PHOENIX 2.4MM X 130CM 7F 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): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: ayse kharodawala ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4063
• MDR Report Key: 25898702
• Report Number: 3007284006-2026-00397
• Device Sequence Number: 6000795
• Product Code: MCW
• UDI-Device Identifier: 00845225003593
• UDI-Public: (01)00845225003593(11)231128(17)261130(10)4590390010
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PD24130K
• Device Catalogue Number: PD24130K
• Device Lot Number: 4590390010
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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" SPARTACORE GUIDE WIRE; COOK: 7F INTRODUCER SHEATH
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White