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

Model Number	2105-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a: 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.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block g2: foreign- japan.Block h3: the angiosculpt device was returned for evaluation.Visual inspection found the distal bond peeled, but remained intact to the device.During functional testing, using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm a pinhole balloon rupture was observed on the distal portion of the balloon.Block h6: the ifu warns at least 99.9% of the balloons (with 95% confidence) will not burst at or below the rbp.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 the distal radial artery.During inflation below nominal pressure (8 atm), the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.

• 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: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 719377-8986
• MDR Report Key: 16974080
• Report Number: 3005462046-2023-00016
• Device Sequence Number: 6659360
• Product Code: PNO
• UDI-Device Identifier: 00813132021450
• UDI-Public: 00813132021450
• 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): 05/22/2023

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: 05/11/2025
• Device Model Number: 2105-6040
• Device Catalogue Number: 2105-6040
• Device Lot Number: G22050047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• 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: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown