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

Model Number 410-152

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluations: wrinkling of the jacket near the distal tip and approximately 1/3 of the fibers were dead at the tip.There were several defects in the outer jacket between 35-46 inches from the distal tip where there were exposed fibers.The excessive fiber damage and wrinkling of the jacket indicate excessive forces applied to the catheter during use.There is no indication that these defects were caused by a failure in the design or manufacturing of the device.

Event Description

Vascular intervention case to treat the left tibial arteries.The physician began the procedure with the turbo elite and then used a balloon.Upon completion of pta the physician decided to attempt treatment with the turbo elite again when it was noted that light was visible through the outer sheath.Use of the device was discontinued without harm to the patient and was completed using pta.Upon device evaluation it was noted that there were several compromises in the device outer jacket resulting in potential exposure of manufacturing materials and inadvertent exposure to laser energy.

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; 9945 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5998925
• MDR Text Key: 57266031
• Report Number: 1721279-2016-00136
• 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
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2016
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD16D01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided; 07/24/2017
• Supplement Dates FDA Received: 03/23/2017; 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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: PTA BALLOON (UNK MAN.); SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Other