MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-006

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Device evaluation: a visual inspection of the catheter was performed with no bend to the catheter.There was a breach seen to the jacket ~1/4inch from the tip of the catheter.

Event Description

During a patient procedure, the physician had difficulty advancing the laser catheter through a sheath.It was reported that the tip of the laser catheter looked and felt bent when the catheter was being loaded onto the wire.The device was removed and the procedure was successfully completed with another laser catheter with no reported patient harm.Upon device evaluation, a breach in the jacket discovered.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7118244
• MDR Text Key: 94882708
• Report Number: 1721279-2017-00291
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/23/2019
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA17H17A378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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