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

Model Number 420-159

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient gender, age, and weight were requested, but unavailable from the facility.Upon investigation of suspect catheter's distal tip, no marker band was present.Under microscopic evaluation a void was seen on the side wall of epoxy.Multiple fibers could be seen protruding out of the tip of epoxy.Evaluation confirmed reported issue.

Event Description

A philips representative reported that during an atherectomy procedure to remove a de novo lesion from the superficial femoral artery (sfa), the spectranetics turbo-elite laser catheter 420-159 was utilized.The turbo-elite laser catheter was advanced over the 0.014¿ guidewire, through a 6f sheath, from a pedal approach.The laser catheter advanced without issue, but the physician noted that the tip of the laser catheter (the radiopaque marker) was moving back and forth under x-ray, while he kept the laser catheter stationary.When he removed the laser catheter from the patient it was noticed that the radiopaque marker was not attached to tip of the laser catheter, and was still on the guidewire within the patient.The physician elected to stent across the radiopaque marker to the vessel wall.The radiopaque marker was then fixed in the patient¿s superficial femoral artery (sfa), and remained there post procedure.No further intervention was implemented.

• Brand Name: 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: 7987513
• MDR Text Key: 124490836
• Report Number: 1721279-2018-00149
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: 00813132024765
• 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: 01/01/2005,09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH18G18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• 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: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• 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): Other; Required Intervention