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

Model Number 423-001

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: upon evaluation, the catheter was calibrated without difficulty, there were 4 dead fibers seen in the device.No other damage was found and no components were missing.

Event Description

Vascular intervention case to treat isr.A turbo elite was utilized, during the case embolic debris was noted.The particles were extracted from the vessel using an aspiration catheter.The particles appeared to be a part of the patient¿s lesion that was burned by the catheter.The patient did not experience decline or additional adverse effects.

Manufacturer Narrative

Follow up to provide patient''s dob and weight.

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: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6302607
• MDR Text Key: 66555221
• Report Number: 1721279-2017-00018
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/15/2018
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC16E04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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: SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65