MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION STELLAREX 0.035" OTW DRUG-COATED ANGIOPLASTY BALLOON; DRUG-ELUTING PTA CATHETER

Model Number	AB35SX060200135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks a2-a6: patient information is 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 stellarex device was not returned, thus no product evaluation was performed.Block h6: per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.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
A stellarex device was used in the mid sfa.During the first inflation at 6 atm, the balloon ruptured.A new stellarex device was used to complete the procedure.No patient injury reported.This product problem is being submitted per fda request because the balloon ruptured below rbp.
Additional Manufacturer Narrative
Block h3: the stellarex device was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing, using a syringe filled with water, the balloon was pressurized to 1 atm, and a pinhole leak was confirmed in the middle of the balloon.Block h6: per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.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: STELLAREX 0.035" OTW DRUG-COATED ANGIOPLASTY BALLOON
• Common Device Name: DRUG-ELUTING PTA CATHETER
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: ana tan ; 5905 nathan lane north; plymouth, MN 55442 ; 858720-4037
• MDR Report Key: 22411552
• Report Number: 3016257349-2025-00002
• Device Sequence Number: 15869133
• Product Code: ONU
• UDI-Device Identifier: 00810060550427
• UDI-Public: (01)00810060550427(11)250116(17)270116(10)0303373805
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 07/30/2025

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: AB35SX060200135
• Device Catalogue Number: AB35SX060200135
• Device Lot Number: 0303373805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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: TERUMO: 0.035" GLIDEWIRE ADVANTAGE GUIDE WIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Sex: Unknown