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

Model Number 423-135-02

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261); Peeled/Delaminated (1454)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

On 21-mar-2019 the suspect turbo-elite device was evaluated.During visual inspection it was determined that no marker band was returned and the catheter jacket was completely charred at tip, indicating that the tip of the device got extra hot (likely due to lack of saline hydration while lasering).Under microscopic evaluation it could be seen that the epoxy plug to which the marker band connects, had melted off.The catheter jacket was also melted and peeled back, approximately 5mm from catheter tip, exposing laser fibers that had ablated on themselves.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

Event Description

A philips representative reported that during a peripheral atherectomy procedure to treat a severely calcified lesion of the superficial femoral artery (sfa), that a spectranetics turbo-elite peripheral laser atherectomy catheter 423-135-02 was utilized.During use of the laser catheter within the patient, when the physician pulled the catheter back, the radiopaque marker band tip was left behind in the vessel.The physician was able to retrieve the marker band tip with a balloon.No harm to the patient.

• Brand Name: SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8446159
• MDR Text Key: 139677124
• Report Number: 1721279-2019-00053
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: 423-135-02
• Device Catalogue Number: 423-135-02
• Device Lot Number: FBN18J06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 79