MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-006

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

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Shaking/Tremors (2515); Test Result (2695)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Patient date of birth and age unavailable.Patient weight unavailable.

Event Description

A procedure using a turbo elite device went well with no initial patient complication.When patient ambulated 2 hours post procedure, he experienced shaking, decreased blood pressure, elevated heart rate; the patient was also febrile with white blood cell count of 16 and a yellow hue to his hands.The patient was taken to icu.This report is being filed because the event occurred 2 hours post procedure.No injury was identified; cause of symptoms unknown.The report stated that the patient's symptoms were not attributed to the laser, but are unable to be explained.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6969067
• MDR Text Key: 89966304
• Report Number: 1721279-2017-00241
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/07/2019
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA17HO2A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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: SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Other