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

Model Number	2105-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: the patient's dob is unknown.This information was not available from the facility.Blocks e1 & g2: foreign- germany.Block h3: the angiosculpt catheter was returned intact to a non-philips introducer sheath; however, was able to be removed from the catheter with no resistance.Visual inspection of the catheter found a damaged balloon that burst radially.No functional testing performed due to the nature of the returned catheter.Block h6: the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.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 device was used for a peripheral procedure in the distal cephalic vein.During the second inflation, the balloon ruptured at nominal pressure (8 atm).The procedure was completed with a new angiosculpt device.No patient injury reported.During the returned product evaluation, visual inspection confirmed a balloon radial burst.This product problem is being submitted due to the balloon radial burst that can result in a 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: danielle bullock ; 5055 brandin court; fremont, CA 94538 ; 858720-4125
• MDR Report Key: 24272036
• Report Number: 3005462046-2026-00007
• Device Sequence Number: 10031054
• Product Code: PNO
• UDI-Device Identifier: 00813132021450
• UDI-Public: (01)00813132021450(17)270521(10)G24050018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 2105-6040
• Device Catalogue Number: 2105-6040
• Device Lot Number: G24050018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: CORDIS: 7F BRITE INTRODUCER SHEATH; TERUMO: 0.018" ADVANTAGE GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White