MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA; CATHETER, PTA, 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	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The angiosculpt device was used to treat the left sfa.Upon removal, the catheter separated in the patient.A snare was used, but only a portion of the device was retrieved.The other portion was retained in the patient.This adverse event and product problem is being submitted due to the shaft separation requiring medical intervention, but partial device was retained in patient.
Additional Manufacturer Narrative
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.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Attempts to obtain the information has not been successful.The angiosculpt device was not returned for evaluation by the facility, thus no returned product investigation was performed.Per the ifu, retained device component is listed as a possible adverse effects of the procedure.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 OTW PTA
• Common Device Name: CATHETER, PTA, 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: ana tan ; 5055 brandin court; fremont, CA 94538 ; 570673-2239
• MDR Report Key: 16390413
• Report Number: 3005462046-2023-00006
• Device Sequence Number: 14831472
• Product Code: PNO
• UDI-Device Identifier: 00813132022846
• UDI-Public: 00813132022846
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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: 04/13/2023
• Device Model Number: 2237-60100
• Device Catalogue Number: 2237-60100
• Device Lot Number: G21040027
• 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: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: UNKNOWN MFG AND SIZE: GUIDE CATHETER.; UNKNOWN MFG AND SIZE: GUIDEWIRE.; UNKNOWN MFG AND SIZE: INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown