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

Model Number 410-152

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Stenosis (2263); Injury (2348)

Event Date 01/26/2017

Event Type  Injury  

Event Description

Vascular intervention case to treat stenosis in the sfa.During use of the turbo elite a tear occurred in the sfa vessel wall.A balloon was placed for 5 minutes to tamponade to injury.Upon further fluoroscopic evaluation the tear was noted to have stopped bleeding.No additional adverse outcome was experienced by the patient.

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; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6284942
• MDR Text Key: 66006198
• Report Number: 1721279-2017-00016
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/20/2017
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD15C20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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
• Treatment: BOSTON SCIENTIFIC BALLOON; CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 36