MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3010
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign- taiwan.Visual inspection found a damaged distal tip and a damaged distal bond with one leaflet lifted, but remained intact.During functional testing, using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a longitudinal balloon tear was observed.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.Additionally, retained device component is listed as possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid lad.During inflation at 16 atm, the balloon ruptured.The procedure was completed with a different device.No patient injury reported.During the device evaluation, the balloon rupture was confirmed and a distal bond peel was observed.This product problem is being submitted conservatively because the balloon ruptured below rbp and the distal bond peeled.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, 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: 14213657
• Report Number: 3005462046-2022-00017
• Device Sequence Number: 16595117
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P050018
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 01/16/2023
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G20010019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• 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: 03/30/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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: ASAHI: 0.014" SION GUIDEWIRE; MEDTRONIC: 6F LAUNCHER GUIDE CATHETER
• Patient Age: 64 YR
• Patient Sex: Male