MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA; CATHETER, PTA, CUTTING/SCORING

Model Number	2290-40100
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient''s dob is unknown.This information was not available from the facility.Report source: foreign- germany.The angiosculpt device was not returned by the facility, thus no returned product investigation was performed.Based on the complaint details, force was applied to remove from the patient.This likely resulted in the detachment of the scoring element resulting in a sharp edge.Photo received shows the scoring element detached, but remained intact to the device.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 in the mid sfa.During removal, resistance was noted and the device was knotted at the vessel site.With much force applied, the device was able to be removed but the patient experienced a lot of pain.Upon removal, the scoring element was knotted and one scoring element strut detached, but remained intact.The procedure was completed with a plain balloon.Under angiography, no damage to the vessel was observed.No patient injury reported.This product problem is being submitted due to the detached scoring element strut resulting in a sharp edge.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h3: the angiosculpt catheter was returned for evaluation.Visual inspection found the scoring element ring detached from the damaged distal bond.One scoring element strut detached at the distal portion, but remained intact with a sharp edge observed.Block h6: in the initial mdr, investigation findings code #3252 (fracture problem) was listed and remains appropriate.Per the ifu, retained device components 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
• MDR Report Key: 15200152
• Report Number: 3005462046-2022-00043
• Device Sequence Number: 2162470
• Product Code: PNO
• UDI-Device Identifier: 00813132022938
• UDI-Public: 00813132022938
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 12/03/2023
• Device Model Number: 2290-40100
• Device Catalogue Number: 2290-40100
• Device Lot Number: G21120008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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: DURA INTRODUCER SHEATH MFG AND SIZE UNK; TERUMO: 0.018" ADVANTAGE GUIDEWIRE
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White