MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER TURBO ELITE

Model Number 414-151

Device Problem Nonstandard Device (1420)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the facility. Visual and microscopic evaluation of the suspect device found a fiber sticking out of the bifurcate, not broken out of jacket. Appears to have occurred during manufacturing process. Fiber is active. No other damage to the rest of the catheter detected.

Event Description

A philips representative reported that during preoperation for a peripheral atherectomy procedure, the integrity of the turbo-elite atherectomy 414-151 catheter was questioned. The device was removed from the procedure and a second turbo-elite atherectomy 414-151 catheter was used instead. Procedure completed successfully, with no harm to the patient or user. The device was returned to the manufacturer for evaluation and it was determined on 30-nov-2018, that the catheter had exposed laser fibers outside of the catheter sheath. 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 LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8201178
• MDR Text Key: 131626410
• Report Number: 1721279-2018-00181
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/13/2020
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY18J07A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/27/2018 Patient Sequence Number: 1