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

Model Number	2092-6040
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks a2/a3b/a4/a5/a6: the patient's dob, gender, weight, ethnicity, and race 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.Blocks e1/g2: foreign- japan block h3: the angiosculpt catheter was returned for evaluation.Visual inspection found a partially inflated balloon and a separated scoring element.No functional testing performed due to the nature of the returned catheter.Block h6: based on the device analysis, the probable cause of the scoring element separation is likely due to the user not fully deflating the balloon, which required force for removal; resulting in the separation.Per ifu, apply negative pressure to the inflation device and confirm that the balloon is fully deflated prior to removing the angiosculpt catheter.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
An angiosculpt catheter was used for a peripheral arteriovenous (av) shunt procedure.During advancement, the balloon could not cross through the anastomosis site.When attempting to withdraw the uninflated balloon from the sheath, it became stuck inside and could not be retrieved.Strong traction was applied to the shaft but the scoring element separated; removing the sheath and catheter together.The separated scoring element was able to be removed since it was protruding through the skin, keeping the guidewire in place.The procedure was completed with a new angiosculpt device.No patient injury reported.Although the complaint details state the balloon was uninflated, a photo provided by the customer shows an inflated balloon.This product problem is being submitted due to scoring element separation; potential for harm.

• 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: 24945014
• Report Number: 3005462046-2026-00014
• Device Sequence Number: 5406583
• Product Code: PNO
• UDI-Device Identifier: 00813132021436
• UDI-Public: (01)00813132021436(17)281106(10)0303626346
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: 0303626346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: 0.018" GUIDEWIRE, UNK MFG; MEDIKIT: INTRODUCER SHEATH, UNK SIZE; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Age: 40 YR
• Patient Sex: Male