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

Model Number	AB35SX050200135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a3b: patient's gender was inadvertently missed in the initial mdr.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.
Additional Manufacturer Narrative
Block a3b: the patient's gender is unknown.This information was not available from the facility.Block h3: the stellarex device was returned for evaluation.Visual inspection found a pinhole on the distal side of the balloon.During functional testing, using a syringe filled with water, the balloon was pressurized and at 1 atm, a pinhole leak was confirmed at the distal side of the balloon.Block h6: per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.Based on the complaint details, a probable root cause may be due to lesion morphology (severely calcified lesion).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 a severely calcified proximal sfa.During the first inflation below rbp, 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.

• 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: diana melliza galvez ; 5905 nathan lane north; plymouth, MN 55442 ; 510933-4541
• MDR Report Key: 19528066
• Report Number: 3016257349-2024-00002
• Device Sequence Number: 12656253
• Product Code: ONU
• UDI-Device Identifier: 00810060550281
• UDI-Public: (01)00810060550281(11)240221(17)260221(10)0303121540
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Expiration Date: 02/21/2026
• Device Model Number: AB35SX050200135
• Device Catalogue Number: AB35SX050200135
• Device Lot Number: 0303121540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/01/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: BIOTRONIK: 6F INTRODUCER SHEATH; CORDIS: 6F GUIDE CATHETER; CSI: 0.014" VIPER WIRE GUIDE WIRE
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White