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

Model Number	420-050
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth, age unk a4): patient''s weight unk d4): device serial number unk h3/h6): the device was returned to the manufacturer; however, the evaluation has not yet begun.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.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
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the proximal superficial femoral artery (sfa).Prior to use of spectranetics devices, multiple tools (cook medical 6f introducer sheath, bd rotarex excisional atherectomy system) were used to begin the procedure.Per report, the rotarex distal tip broke off inside the cook sheath, and a snare was used to remove the separated portion.Then, a spectranetics turbo-power laser atherectomy catheter was loaded over a guide wire and inserted through the same cook sheath.After treatment and during removal, the turbo-power was stuck within the sheath, necessitating removal as a unit.Upon observation, exposed fibers and separation of the catheter were noted.In addition, the cook sheath''s coils/braids were loose and unraveled, bound against the turbo-power.The procedure was completed with no reported patient harm.This event is being submitted for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B5): new information stated that the device was being used in-stent.G3): the device evaluation and investigation were completed 25mar2024.H3): the turbo-power was returned intact to an 0.014 non-philips guide wire, along with portions of a cook medical introducer sheath.Visual inspection of the turbo-power found wrinkles present along the working length, and a 3 cm breach of the outer jacket was noted, 64 cm proximal to the distal tip.In the area of the breach, exposed fibers were present, but not broken, and the inner lumen was visible.Additionally, the guide wire was protruding from the turbo-power proximal end and distal tip.Coils and portions of the inner lumen from the cook were wrapped around the outer jacket of the turbo-power, spanning 64 cm from the distal tip.The cook shaft was detached from the valve, and the valve was stuck on the turbo-power, 64 cm from the distal tip.Beyond the turbo-power distal tip, portions of the cook inner lumen were found stuck within the coils.During functional testing, the outer jacket was incised, which confirmed the inner lumen was intact, and heavy biologics were observed.H6): based on additional information and device evaluation, challenges with the rotarex device before use of the turbo-power, and the turbo-power being used in-stent, may have contributed to the damage observed.However, the cause of the reported failure could not be established.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: TURBO-POWER LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 18867892
• Report Number: 3007284006-2024-00055
• Device Sequence Number: 15383765
• Product Code: MCW
• UDI-Device Identifier: 00813132026783
• UDI-Public: (01)00813132026783(17)240607(10)FTS22E17A
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 06/07/2024
• Device Model Number: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: FTS22E17A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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: BD ROTAREX EXCISIONAL ATHERECTOMY SYSTEM; COOK MEDICAL 6F INTRODUCER SHEATH; GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American