MAUDE Adverse Event Report: Spectranetics Corporation AngioSculpt OTW PTA Scoring Balloon Catheter; Catheter, Percutaneous, Cutting/Scoring

Model Number	2334-7040
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An angiosculpt catheter was used for a therapeutic peripheral procedure in the sfa.During inflation, the balloon immediately burst below rbp (rbp:14 atm) (device evaluated; no leak observed).A second angiosculpt was used; however, the balloon popped instantly upon inflation (rbp:12 atm).The angiosculpt and concomitant devices were removed all together.The procedure was completed with a non-angiosculpt.No patient injury reported.This product problem is being submitted for the second angiosculpt for balloon rupture and removal as a system; potential for harm.
Additional Manufacturer Narrative
Blocks a2-a6: the patient's dob or age at time of event, gender, sex, 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.Block h3: the angiosculpt device was returned intact to the introducer sheath, which aligns with the reported complaint.Visual inspection found a longitudinal tear on the entire length of the balloon, and the balloon detached from the distal end.The scoring element was damaged, and the struts, except for one, detached at the intermediate bond; resulting in sharp edges.However, it is unknown when the scoring element damage occurred, as this was not mentioned in the complaint details.Additionally, the distal shaft was stretched, and the transition tubing was accordioned.No functional testing performed due to the nature of the returned device.Block h6: the root cause of the balloon rupture could not be established.However, a probable cause of the catheter damage may be due to some degree of force applied by the user during removal.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.Additionally, the device history record (dhr) was reviewed, and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.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
• 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 ; +1(510)933-4541
• MDR Report Key: 50821269
• Report Number: 3005462046-2026-00063
• Device Sequence Number: 21370429
• Product Code: PNO
• UDI-Device Identifier: 00813132022235
• UDI-Public: (01)00813132022235(17)290225(10)0303715768
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• 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): 09/18/2026

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: 2334-7040
• Device Catalogue Number: 2334-7040
• Device Lot Number: 0303715768
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2026
• 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: Unk Mfg and Size: Guide Catheter; Unk Mfg and Size: Guidewire; Unk Mfg and Size: Introducer Sheath
• Patient Sex: Unknown