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

Model Number	2200-2010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
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.Foreign: (b)(6).Visual inspection found no unusual characteristics of 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 leak was present in the middle of the balloon.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid lad.During the second inflation at 18 atm, 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 RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 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
• MDR Report Key: 13323225
• Report Number: 3005462046-2022-00004
• Device Sequence Number: 12017799
• Product Code: NWX
• UDI-Device Identifier: 00813132021146
• UDI-Public: 00813132021146
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 01/14/2023
• Device Model Number: 2200-2010
• Device Catalogue Number: 2200-2010
• Device Lot Number: G20010017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• 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: 01/04/2022
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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" GUIDEWIRE; MEDTRONIC: 6F GUIDE CATHETER
• Patient Age: 64 YR
• Patient Sex: Male