MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION STELLAREX 035; DCB PTA CATHETER

Model Number	AB35SX060060135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient''s dob or age at time of event, 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 discarded by the facility, thus no returned product investigation was performed.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 inflation at 8 atm, a balloon pinhole leak was observed, caused by a stent strut inside the stent.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 035
• Common Device Name: DCB PTA CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer (Section G): SPECTRANETICS; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer Contact: diana melliza galvez ; 6655 wedgwood road north; suite 105; maple grove, MN 55311 ; 719377-8986
• MDR Report Key: 16414810
• Report Number: 3011416935-2023-00003
• Device Sequence Number: 19674127
• Product Code: ONU
• UDI-Device Identifier: 00813132024291
• UDI-Public: 00813132024291
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 02/21/2023

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: 01/28/2023
• Device Model Number: AB35SX060060135
• Device Catalogue Number: AB35SX060060135
• Device Lot Number: FVY20M24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: MEDTRONIC: 0.014" SPIDERFX EMBOLIC; TERUMO: 6F DESTINATION SHEATH
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American