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

Model Number	2200-3010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: the patient's dob is unknown.This information was not available from the facility.Block g2: foreign- south korea block h3: the angiosculpt device was not returned, thus no returned product investigation was performed.Block h6: 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
The angiosculpt device was used to treat a mid-lad artery.During inflation at 16 atm, the balloon burst.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.
Additional Manufacturer Narrative
Block b5/h2: this event is no longer reportable based on the observations from the returned product analysis.No balloon rupture was observed as described in the complaint details.Block h3: the angiosculpt device was returned for evaluation.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 up to 16 atm, and a leak was observed on the intermediate shaft.Based on the lab analysis, the reported complaint of a balloon rupture could not be replicated; however, a shaft leak was noted.Per the manufacturer''s work instruction, a shaft leak is not considered a reportable event.Block h6: the cause of the shaft leak could not be established.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
Initial mdr reported a balloon rupture below rbp.However, based on the observations from the returned product analysis, no balloon rupture was observed as described in the complaint details.Therefore, this event is no longer reportable.

• 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 ; 719377-8986
• MDR Report Key: 17130891
• Report Number: 3005462046-2023-00023
• Device Sequence Number: 7434887
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: (01)00813132021207(17)250930(10)G22090055
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 09/30/2025
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G22090055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: 0.014" GUIDEWIRE, UNK MFG.; 6F GUIDE CATHETER UNK MFG.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian