MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2105-6040
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks a2/a3b/a4: the patient's dob or age at time of event, sex, gender, and weight are unknown.This information was not available from the facility.Blocks b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block g2: foreign- japan.Block h3: the angiosculpt catheter was returned intact to an 0.018" non-philips guidewire.Visual inspection found an accordioned (damaged) guidewire lumen at the luer/hub area.During functional testing, an attempt was made to remove the guidewire from the catheter but was unsuccessful.Block h6: based on the device analysis, a probable root cause may be due to the damaged guidewire lumen preventing the catheter from being removed separately from the guidewire; however, the cause could not be established.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
The angiosculpt catheter was used to treat a peripheral lesion.After balloon inflation, the non-philips guidewire got stuck inside the patient; thus, the catheter and guidewire were removed as a system.The procedure was completed with a non-angiosculpt catheter.No patient injury reported.This product problem is being submitted due to removal as a system.There is potential for harm if it were to recur.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-4541
• MDR Report Key: 21415411
• Report Number: 3005462046-2025-00004
• Device Sequence Number: 9208358
• Product Code: PNO
• UDI-Device Identifier: 00813132021450
• UDI-Public: (01)00813132021450(17)260724(10)G23070018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• 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): 02/19/2025

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: 07/24/2026
• Device Model Number: 2105-6040
• Device Catalogue Number: 2105-6040
• Device Lot Number: G23070018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: MEDIKIT: 7F INTRODUCER SHEATH.; TERUMO: 0.018" RADIFOCUS GUIDEWIRE.; UNK MFG AND SIZE: GUIDE CATHETER.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian