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

Model Number	2249-60200
Medical Device Problem Codes	Material Rupture (1546); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used to treat a moderately calcified distal sfa and proximal pop.During inflation, the balloon ruptured at 6 atm and the balloon and sheath were removed together.A new sheath and new balloon was used to complete the procedure.No patient injury reported.During the returned product analysis, the balloon rupture was confirmed and one scoring element strut was detached with a sharp edge observed.This product problem is being submitted for a balloon rupture below rbp and the sharp edge observed.The balloon rupture is being reported conservatively, and the sharp edge has a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
The angiosculpt device was returned loaded onto a non-philips introducer sheath.Visual inspection found a damaged scoring element.One scoring element strut detached, but remained intact to the device; however, exposed a sharp edge.An attempt to remove the angiosculpt device from the introducer sheath was performed; but unable due to the damaged scoring element.During functional testing, using an indeflator filled with green color dye water, the balloon was inflated and at less than 2 atm, a pinhole leak was observed on the proximal portion of the balloon.(b)(4).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.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510673-2239
• MDR Report Key: 16092048
• Report Number: 3005462046-2023-00001
• Device Sequence Number: 12394330
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• 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): 01/03/2023

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: 03/09/2024
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G22030015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• 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: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: 0.014" COMMAND GUIDEWIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Sex: Unknown