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

Model Number 420-006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth unk, b6): relevant tests/laboratory data unk, b7): other relevant history unk, h3): the device was discarded, thus no investigation could be completed.H6): embolization is a known risk of complication with use of the turbo-elite 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 Description

A peripheral atherectomy procedure commenced to treat a slightly calcified plaque lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.After the atherectomy was completed, it was discovered that a clot had embolized distally into the patient's tibial arteries.Tissue plasminogen activator (tpa) was administered to dissolve the clot, and the patient survived the procedure.This report captures the turbo-elite in use when an embolism occurred, requiring intervention.There was no alleged malfunction of the turbo-elite device in use during the procedure.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18271017
• MDR Text Key: 329774898
• Report Number: 3007284006-2023-00083
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA23J11A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CSI SHEPHERD 0.014 GUIDE WIRE; GUIDE CATHETER MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White