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

Model Number	423-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was discarded, thus no investigation could be completed.Although embolism is a known risk of complication with use of the turbo-power device, the physician stated that there was pre-existing thrombus within the stents prior to the turbo-power being used and expected a potential embolization.Investigation determined this event to be use error, for not using mechanical thrombectomy prior to utilization of the turbo-power.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
As part of a japan turbo postmarket study, a peripheral atherectomy procedure began to treat an in-stent restenosis (isr) in the patient's mid superficial femoral artery (sfa) to the popliteal region.The lesion to be treated was 400 mm in length, with heavy thrombus present within the stents.It was predicted that treatment would result in clots and potential embolism; therefore, a filter was placed pre-procedure, distal to the lesion.The physician chose to treat the patient with a spectranetics turbo-power laser atherectomy catheter.During use, and as expected, portions of the thrombus were observed.The filter did not catch all the thrombus, resulting in a peripheral embolism.The thrombus that was not captured by the filter was removed successfully using a mechanical thrombectomy catheter.The procedure was completed with no reported patient harm.This report captures the turbo-power in use within the lesion when the peripheral embolism occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15765107
• Report Number: 1721279-2022-00193
• Device Sequence Number: 6353508
• Product Code: MCW
• UDI-Device Identifier: 00813132026776
• UDI-Public: (01)00813132026776(17)240523(10)FMP22E06A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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: 05/23/2024
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: FMP22E06A
• 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: 10/18/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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: GUIDE CATHETER MANUFACTURER AND SIZE UNK.; GUIDE WIRE MANUFACTURER AND SIZE UNK.; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian