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

Model Number	2216-30100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used in a peripheral procedure of a slightly fibrous distal sfa.After inflation at 12 atm, the balloon was unable to deflate and got stuck but removed successfully without additional intervention.Upon removal, it was observed that the scoring element detached from the balloon but remained intact to the device.The procedure was completed with a new balloon.No patient injury reported.This product problem is being submitted due to the balloon unable to deflate, potential for harm.
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, and weight are unknown.This information was not available from the facility.Block b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Block h3/h6: the angiosculpt device was discarded by the facility, thus no product investigation was performed.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.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING
• 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: 23040919
• Report Number: 3005462046-2025-00036
• Device Sequence Number: 10054084
• Product Code: PNO
• UDI-Device Identifier: 00813132022914
• UDI-Public: (01)00813132022914(17)270115(10)G25010009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 2216-30100
• Device Catalogue Number: 2216-30100
• Device Lot Number: G25010009
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ABBOTT: VIPER WIRE GUIDEWIRE, UNK SIZE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White