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

Model Number	2076-4040
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks a2/a3b/a4: the patient's dob or age at time of event, 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.Blocks e1 & g2: foreign- japan block h3: the angiosculpt device was returned intact to an.014 guidewire.Visual inspection found a kinked shaft, distal to the strain relief, and the inner member at the hub was wrinkled and accordioned.During functional testing, the guidewire was unable to be removed from the angiosculpt.Using an indeflator filled with green color dyed water, the balloon was inflated up to 10 atm and was able to maintain pressure.However, the pressure was increased to approx.11 atm, and a hub leak was detected.Block h6: based on the device analysis, the balloon rupture could not be confirmed.A probable root cause of the hub leak is due to the damaged inner member within the hub, which likely caused the guidewire to become stuck.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.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 in a therapeutic peripheral procedure in a severely calcified mid sfa.During inflation at 10 atm (rbp: 14 atm), the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.During the return product evaluation, no balloon leak was observed; however, the angiosculpt was intact to an.014 guidewire.Per additional information received, the angiosculpt came out together with the guidewire.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: 23860490
• Report Number: 3005462046-2025-00045
• Device Sequence Number: 9605747
• Product Code: PNO
• UDI-Device Identifier: 00813132021351
• UDI-Public: (01)00813132021351(17)280115(10)G25010008
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2025

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: 2076-4040
• Device Catalogue Number: 2076-4040
• Device Lot Number: G25010008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: 0.014" GUIDEWIRE, UNK MFG; 6F GUIDE CATHETER, UNK MFG; TERUMO: 6F INTRODUCER SHEATH
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian