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

Model Number	420-159
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth unk h3): the turbo-elite catheter was returned for evaluation.Visual inspection found epoxy degradation and stumping at the distal tip due to heavy use, with significant biologics present.In addition, the distal tip did not appear flattened or frayed as initially reported.A breach to the outer jacket, with broken fibers in the area, was discovered 40 mm from the distal tip.Charring, stretching, and striations were noted at the breach, appearing that a clamp was placed on the device.H6): based on the device evaluation and investigation, the cause of the failure has been determined to be use related.The damage likely resulted from clamping 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
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the proximal superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.During use in the patient, the catheter''s distal tip was noted to be frayed and flattened.Use of the turbo-elite was discontinued and another catheter was used to successfully complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
G3): further device evaluation and investigation were completed 01feb2024.H3): upon further review of the investigation and photos taken during device evaluation, the striations present in the area of the breach did not appear to be those caused by a clamp.The target lesion was severely calcified, as reported in the initial mdr, but inadvertently omitted that the lesion was a chronic total occlusion (cto).H6): based on further investigation, it has been determined that the patient''s condition contributed to the damage at the distal tip.It is likely that during the procedure, the device became caught on an object and pulled, stretching the catheter and creating the striations in the outer jacket.However, the cause of the breach in the outer jacket and broken fibers could not be established.Conclusions codes corrected to 50 and 4315 (from 61).All other codes remain applicable as listed in the initial mdr.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-ELITE 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: 18242842
• Report Number: 3007284006-2023-00072
• Device Sequence Number: 12539782
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)250816(10)FBH23H10A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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: 08/16/2025
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH23H10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• 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: 11/30/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: COOK MEDICAL 6F INTRODUCER SHEATH; CORDIS 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American