MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 410-152

Device Problems Material Frayed (1262); Difficult to Advance (2920)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluation: distal to the luer 11. 5 inches, the outer jacket is broken with exposed fibers.

Event Description

Vascular intervention procedure in an anterior tibial artery due to severe calcification. The catheter jacket frayed as the physician was trying to advance the laser fiber. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation. The procedure was completed by other means, and the patient was discharged per operative plan.

• 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: 6527540
• MDR Text Key: 207100965
• Report Number: 1721279-2017-00073
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2019
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD17C14A015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2017 Patient Sequence Number: 1

Treatment

SPECTRANETICS CVX-300 EXCIMER LASER