MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

Model Number 420-006

Device Problems Melted (1385); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

This device was returned to spnc without any information available from the facility staff.The date of this case is unknown.The physician, facility staff and the inventory manager were all interviewed and they were unable to provide any details regarding this device.Upon physical evaluation of the device; several dead fibers and melting of the outer jacket with exposed fibers were seen in the distal tip.This report is to reflect the potential for patient exposure to manufacturing materials from this jacket compromise.

Manufacturer Narrative

(b)(4).This device was returned for evaluation by a cross functional engineering team.The working length of the catheter had two locations of damage.The first point of damage was 1.5 inches from the distal tip and appeared to be from some sort of clamp that had been applied.The second point of damage had exposed fibers and manufacturing materials 4.5 inches from the distal tip.This damage appeared to have been caused by kinking during use.The lhr review did not reveal any manufacturing non-conformances that would cause this.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 4767180
• MDR Text Key: 5950962
• Report Number: 1721279-2015-00081
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060012
• 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: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/09/2016
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA14J09A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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 LASER SYSTEM
• Patient Outcome(s): Other