MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	423-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135); Rupture (2208); Iatrogenic Source (2498)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unavailable.
Event or Problem Description
A philips representative became aware on 01 dec 2020 that a peripheral atherectomy procedure commenced on (b)(6) 2020 to treat a severely calcified lesion in the patient's mid superficial femoral artery (sfa).This procedure was part of a postmarket study conducted in japan.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the lesion.After use of the turbo elite catheter, a perforation was observed (exact location of perforation is unknown).The perforation was then treated with a plain old balloon angioplasty (poba), non drug coated, and the patient survived the procedure.There was no alleged malfunction of the turbo elite device during use in the procedure.
Additional Manufacturer Narrative
B5): additional and corrected case detail was provided in journal article.D10): concomitant devices added.G2): additional/corrected information obtained from journal article.G3): manufacturer became aware of journal article 15nov2022.H6): hecc codes 2135 and 2208 corrected from historical codes 2498 and 2001.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
Updated information received from journal article (jacc: cardiocascular interventions, vol.14, no.23, 2021) on 15nov2022: the patient underwent the procedure for in-stent occlusion (iso).The guide wire supported with a microcatheter entered the proximal iso but could not advance any further due to hard plaque.The turbo elite advanced slowly, but was unable to pass the stents'' overlapped area due to resistance.Using a zemporshe ovalis angioscope and a philips vision pv.018 ivus catheter, an arterial perforation and rupture was identified in the tissue covering the stent, due to use of the turbo elite.Hemostasis and successful recanalization was achieved with implantation of an endovascular stent graft.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 11055418
• Report Number: 1721279-2020-00259
• Device Sequence Number: 2694733
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)210930(10)FBC19J25A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC19J25A
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• 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 MANUFACTURER UNKNOWN; 7F INTRODUCER SHEATH MANUFACTURER UNKNOWN; MICROCATHETER MANUFACTURER AND SIZE UNK; PHILIPS VISIONS PV .018 IVUS CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ZEMPORSHE OVALIS ELECTRONIC ANGIOSCOPE; 0.014 GUIDEWIRE MANUFACTURER UNKNOWN; 7F INTRODUCER SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown