MAUDE Adverse Event Report: STELLAREX 035; DCB 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	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob and weight are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.The stellarex device was returned for evaluation.Visual examination found no unusual characteristics of the device.During functional testing using a syringe filled with water, the device was pressurized and at less than 1 atm, a pinhole leak on the balloon was present.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
Event or Problem Description
The stellarex device was used to treat a moderately tortuous and a severely calcified mid sfa.During inflation at 2 atm, the balloon burst due to heavily calcified edges.The balloon was removed in one piece and the procedure was completed with a new stellarex device.No patient injury reported.This product problem is being submitted per fda request because the balloon ruptured below rbp.

• Brand Name: STELLAREX 035
• Common Device Name: DCB PTA CATHETER
• MDR Report Key: 12701517
• Report Number: 3011416935-2021-00044
• Device Sequence Number: 4613992
• Product Code: ONU
• UDI-Device Identifier: 00813132026981
• UDI-Public: 00813132026981
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/04/2021

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: 07/31/2022
• Device Model Number: AB35SX060200135
• Device Catalogue Number: AB35SX060200135
• Device Lot Number: F8J20G01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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: MERIT: 0.035" GO2 GUIDEWIRE; TERUMO: 6F SLENDER INTRODUCER SHEATH
• Patient Age: 78 YR