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

Model Number AB35SX060200135

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

Block a4: the patient''s weight is unknown.This information was not available from the facility.Blocks b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Block h3: the stellarex device was discarded by the facility, thus no returned product investigation was performed.Based on the complaint details, a probable root cause may be due to lesion morphology (severely calcified lesion).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 Description

A stellarex device was used a severely calcified mid sfa.During inflation at 10 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.

• Brand Name: STELLAREX 0.035" OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: 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 ; 510933-454
• MDR Report Key: 19074185
• MDR Text Key: 339745870
• Report Number: 3016257349-2024-00001
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00813132029173
• UDI-Public: (01)00813132029173(17)240815(10)P5822G06A(11)220815
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: AB35SX060200135
• Device Catalogue Number: AB35SX060200135
• Device Lot Number: P5822G06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO: 0.035" GLIDEWIRE GUIDEWIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White