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

Model Number	2105-6040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An angiosculpt catheter was used for a peripheral therapeutic procedure in a moderately tortuous av shunt.During use, at initial inflation, the balloon ruptured at 14 atm (rbp).When the catheter was being removed, resistance was encountered, and the balloon with the distal tip separated within the patient (photo provided).The remaining portion of the catheter, including the scoring element, was removed from the patient.The retained balloon was subsequently retrieved with a snare, and angiogram confirmed nothing was left in the patient.The procedure was completed with no patient injury reported.This adverse event and product problem is being submitted for balloon rupture and separation; requiring intervention.
Additional Manufacturer Narrative
Blocks a2/a3b/a4: date of birth, age, gender, and weight, not available from 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 g2: foreign- japan.Block h3: the angiosculpt catheter was returned in two pieces.One portion includes the balloon with the distal tip, and the other portion is the remainder of the catheter, which includes the scoring element, shaft, and hub.Visual inspection found the balloon ruptured radially and separated from the proximal end of the balloon.Under microscopic inspection, the marker bands were present and remained intact, and no other tear was observed on the balloon.Additionally, the distal shaft was stretched/damaged.Block h6: the root cause of the balloon radial tear could not be determined.However, a probable cause of the balloon separation may be due to some degree of force applied by the user when removing the catheter from the undersized sheath (5f).Per the product label, the angiosculpt device is compatible with a 6f sheath.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: danielle bullock ; 5055 brandin court; fremont, CA 94538 ; +1(858)720-4125
• MDR Report Key: 50870253
• Report Number: 3005462046-2026-00065
• Device Sequence Number: 10716069
• Product Code: PNO
• UDI-Device Identifier: 00813132021450
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0303685468
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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: 0.018" Guidewire, Unk Mfg.; 5F Introducer Sheath, Unk Mfg.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Race: Asian