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

Model Number	2334-7040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient''s dob or age at time of event, gender, weight, race, and ethnicity 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.The angiosculpt device was lost at the customer site, thus no returned product investigation was performed.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) 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
Two angiosculpt devices (3005462046-2022-00038) were used to treat a moderately calcified mid iliac.During inflation at nominal pressure, the balloon ruptured.The procedure was completed with a non-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
• MDR Report Key: 15108561
• Report Number: 3005462046-2022-00037
• Device Sequence Number: 5255828
• Product Code: PNO
• UDI-Device Identifier: 00813132022235
• UDI-Public: 00813132022235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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: 05/08/2024
• Device Model Number: 2334-7040
• Device Catalogue Number: 2334-7040
• Device Lot Number: G21050008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2021
• 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: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown