MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ANGIOSCULPT PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2237-60100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An angiosculpt catheter was used in a peripheral procedure to treat a severely calcified mid sfa.The angiosculpt was advanced to the lesion and inflated with no issues.However, during removal, resistance was noted, and the scoring element got stuck in the calcium.Some degree of force was applied, but the scoring element separated in the patient.Attempts to retrieve the scoring element was not successful; therefore, a stent was placed to trap to the vessel wall.This product problem and adverse event is being submitted due to scoring element separation, requiring intervention, but retained in patient.
Additional Manufacturer Narrative
Block a3b: the patient's gender is unknown.This information was not available from the facility.Block h3: the angiosculpt catheter was returned without the scoring element.Visual inspection found a damaged distal tip, distal bond, intermediate bond, transition tubing, and shaft.Block h6: based on the complaint details, the scoring element got stuck in the calcium, and some degree of force was applied, resulting in the scoring element separation.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.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-4541
• MDR Report Key: 21946364
• Report Number: 3005462046-2025-00018
• Device Sequence Number: 12961827
• Product Code: PNO
• UDI-Device Identifier: 00813132022846
• UDI-Public: (01)00813132022846(17)260510(10)G24050010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2026
• Device Model Number: 2237-60100
• Device Catalogue Number: 2237-60100
• Device Lot Number: G24050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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: ABBOTT: 0.014" COMMAND GUIDEWIRE.; TERUMO: 7F INTRODUCER SHEATH.
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White