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

Model Number 410-152

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information unavailable from facility.Device evaluation: the device was returned to the manufacturer and evaluated on 16 july 2020 by a cross functional engineering team.103 cm from the distal tip of the turbo elite device, there was an observable breach identified.Using a 0.014 guide wire through the distal tip of the device, it was determined that the outer jacked was breached with the inner lumen of the device still intact.In the area of the breach, all fibers were broken.Dark spots were identified on the ends of the broken fibers, indicative that lasing occurred after fibers were broken.When dissecting the device's outer jacket, the device separated into two pieces; the outer jacket was holding the device together.This has been determined to be a use related failure.

Event Description

A peripheral vascular intervention procedure commenced to treat a chronic total occlusion (cto) of a moderately calcified popliteal lesion, using a contralateral approach (access to the lesion was gained from the opposite leg).A spectranetics turbo elite laser atherectomy catheter was utilized to treat the lesion.Per report, the physician was holding the device's working length in order to advance the device, and it was becoming difficult to push.During the procedure, the team noticed a break in the laser catheter in the area close to where the physician was holding the catheter, and the team saw red light glowing from the area.At that point, the turbo elite was removed from the body.The physician then used a balloon to finish the procedure.The patient survived the procedure with no reported patient injury.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10311625
• MDR Text Key: 208151050
• Report Number: 1721279-2020-00142
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)220422(10)FBD20D06A
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD20D06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• 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: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2020
• 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): Other