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

Model Number	2092-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used to treat the mid radial artery.During the first inflation at 8 atm, the balloon inflated to a bad shape.The procedure was completed with a new angiosculpt device.No patient injury reported.During the returned product analysis, a pinhole balloon rupture was observed on the distal portion of the balloon.This product problem is being submitted conservatively because the balloon ruptured below rbp.
Additional Manufacturer Narrative
The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Foreign: japan.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 and at less than 2 atm, a pinhole leak was confirmed on the distal 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: 16188922
• Report Number: 3005462046-2023-00003
• Device Sequence Number: 6313492
• Product Code: PNO
• UDI-Device Identifier: 00813132021436
• UDI-Public: 00813132021436
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: 08/01/2025
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: G22080002
• 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: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: BOSTON SCIENTIFIC: 0.018" KYOUSHA GUIDEWIRE.; MEDKIT: 6F ULTRA HIGH FLOW SHEATH/GUIDE.
• Patient Sex: Unknown