MAUDE Adverse Event Report: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER

Model Number 423-050

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unavailable.Facility personnel declined to provide the information.(b)(4).Device evaluation: the working length was stiff approximately 24cm.Fluid was flushed through the device without difficulty.A breach to the outer jacket approximately 3.5cm from the tip was observed.

Event Description

It was reported that prior to a vascular intervention procedure, the end of the device felt "stiff and crunchy".A second turbo power device was opened and the procedure was completed successfully.Evaluation of the returned device revealed a breach to the outer jacket near the tip of the device.This event is being reported due to the potential for exposure to manufacturing materials as well as potential inadvertent exposure to laser energy/radiation.

• Brand Name: TURBO-POWER LASER ATHERECTOMY CATHETER
• Type of Device: TURBO-POWER
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6565422
• MDR Text Key: 75174556
• Report Number: 1721279-2017-00087
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152181
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/08/2019
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: FMP17B03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• 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 SYSTEM
• Patient Outcome(s): Other