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

Model Number 410-152

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Vascular intervention procedure to treat ischemia and severe wounds of the foot.This was a last treatment option to prevent btk amputation.The physician used a turbo elite to lase continuously on a highly calcified lesion.When the physician was unable to advance any further in the lesion the physician attempted to remove the laser catheter.Excessive force was required to remove the catheter.Upon examination the physician felt that the distal tip of the catheter had separated and a portion had been left behind in the lesion.Thrombectomy and ballooning were attempted but the physician was still unable to restore the patient's blood flow to the foot.The patient was scheduled for a btk amputation.

Manufacturer Narrative

Device evaluation: the distal marker band was still in place on the catheter when it was evaluated.The distal tip did show significant damage and evidence of compression.A large part of the tip side was missing; this was likely caused during use.As the description of the case described this was a last effort in trying to save the patient's limb leading to maximum exposure and use of the device in an extremely calcified area resulting in device damage.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• 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
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5430548
• MDR Text Key: 38758972
• Report Number: 1721279-2016-00017
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140775
• 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,Followup,Followup,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/12/2017
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD15H12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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: 79 YR