MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; 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	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The stellarex device was used in a severely calcified proximal sfa.During inflation at 2 atm, the balloon ruptured.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 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• 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: ana tan ; 6655 wedgwood road north; suite 105; maple grove, MN 55311
• MDR Report Key: 14569454
• Report Number: 3011416935-2022-00009
• Device Sequence Number: 5901746
• Product Code: ONU
• UDI-Device Identifier: 00813132026981
• UDI-Public: 00813132026981
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/01/2022

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: 01/08/2023
• Device Model Number: AB35SX060200135
• Device Catalogue Number: AB35SX060200135
• Device Lot Number: F8J20L24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: TERUMO: 0.035" GLIDEWIRE ADVANTAGE GUIDEWIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White