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	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid sfa.During advancement, resistance was noted, but the balloon was inflated with no issues.During removal, resistance was noted again, but this time the device got stuck in the anatomy.Mild degree of force was applied and was able to be removed as a system.Upon removal, the scoring element detached from the balloon; however, it was confirmed that no device fragment was retained inside the patient.A standard balloon was used to complete the procedure.The patient is stable and recovering well, with no injury reported.Photo obtained shows a segment of the scoring element detached, exposing a sharp edge.This product problem is being reported due the sharp edge observed.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block h3: the angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Based on the complaint details, the scoring element got stuck in the anatomy, which required some degree of force for removal.This likely resulted in the detached scoring element, exposing a sharp edge.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: 19088768
• Report Number: 3005462046-2024-00011
• Device Sequence Number: 7071558
• Product Code: PNO
• UDI-Device Identifier: 00813132022846
• UDI-Public: (01)00813132022846(17)240808(10)G22080011
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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: 08/08/2024
• Device Model Number: 2237-60100
• Device Catalogue Number: 2237-60100
• Device Lot Number: G22080011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: ABBOTT: COMMAND GUIDEWIRE, UNK SIZE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Sex: Unknown