MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number	AB35SX060150135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inflation, the balloon ruptured below rbp.No patient injury reported, this mdr is being reported per fda request.The stellarex device was returned for evaluation.Visual examination found presence of blood inside the balloon.During functional testing, the device was pressurized at 1 atm and a pinhole leak was observed in the middle of the balloon.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.In addition, the health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: (b)(4) (no health consequences or impact).
Event or Problem Description
From a contralateral femoral approach, the stellarex device was used to treat the proximal popliteal artery.During inflation at 1 atm, contrast was visibly leaking out of the balloon.The balloon was removed from the body, inflated on the table and a pinhole on the balloon was observed.
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: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510673-2239
• MDR Report Key: 11653902
• Report Number: 3009784280-2021-00040
• Device Sequence Number: 14339313
• Product Code: ONU
• UDI-Device Identifier: 00813132026974
• UDI-Public: 00813132026974
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160049/S004
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• 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): 03/16/2021

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: 06/11/2022
• Device Model Number: AB35SX060150135
• Device Catalogue Number: AB35SX060150135
• Device Lot Number: F7J20E13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/06/2021; 03/09/2022
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/08/2021; 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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: COOK: 6F X 45 CM ANSEL INTRODUCER SHEATH; COOK: BENTSON EXCHANGE GUIDE WIRE, SIZE UNK
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White