MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2334-8040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, gender, sex, weight, ethnicity, and race are unknown.This information was not available from the facility.Block h3: visual inspection found no unusual characteristics of the device.During functional testing, using an indeflator filled with green color dye water, the balloon was inflated to less than 2 atm and a pinhole leak was observed on the distal portion of the balloon.Block h6: the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.Based on the complaint details, a probable root cause may be due to lesion morphology (severely calcified lesion).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
The angiosculpt device was used to treat a severely calcified lesion.During inflation at 6 atm, the balloon ruptured.The procedure was completed with the angiosculpt device.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-4541
• MDR Report Key: 19753139
• Report Number: 3005462046-2024-00020
• Device Sequence Number: 17793684
• Product Code: PNO
• UDI-Device Identifier: 00813132022242
• UDI-Public: (01)00813132022242(17)270207(10)G24020003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/16/2024

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 Model Number: 2334-8040
• Device Catalogue Number: 2334-8040
• Device Lot Number: G24020003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: ABBOTT: 0.018" COMMAND WIRE GUIDEWIRE; TERUMO: INTRODUCER SHEATH, UNK SIZE
• Patient Sex: Unknown