MAUDE Adverse Event Report: SPECTRANETICS 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	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This information was not available from the facility.During inflation, the balloon ruptured below rbp.No patient injury reported, this mdr is being reported per fda request.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, the device was pressurized to 8 atm and a leak was observed on the balloon.Under microscopic inspection, a longitudinal tear was confirmed.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.In addition, (b)(4).
Event or Problem Description
From a retrograde femoral approach, the stellarex device was used to treat a severely calcified mid sfa.During inflation at 8 atm, the device burst.No patient injury reported.
Additional Manufacturer Narrative
Block h6: added codes 419 (balloon) and 2199 (no health consequences or impact).
Additional Manufacturer Narrative
Block h1 (no.Of events (noe) summarized): in the initial report, the xml file shows the summary report and 123 events were included.However, this was inadvertently included due to a system error in the xml file, as it was not visible in the pdf copy.This field should be left blank.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Common Device Name: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 719377-8986
• MDR Report Key: 11864273
• Report Number: 3009784280-2021-00049
• Device Sequence Number: 3241869
• Product Code: ONU
• UDI-Device Identifier: 00813132026981
• UDI-Public: 00813132026981
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160049/S004
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

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: 08/03/2022
• Device Model Number: AB35SX060200135
• Device Catalogue Number: AB35SX060200135
• Device Lot Number: F8J20F23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/06/2021; 03/09/2022
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/08/2021; 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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: TERUMO: DESTINATION SHEATH/GUIDE SIZE UNK; TERUMO: GLIDEWIRE ADVANTAGE, SIZE UNK
• Patient Sex: Unknown