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

Model Number 410-152

Device Problems Crack (1135); Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problems Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight unavailable.

Event Description

A peripheral vascular intervention procedure commenced to treat a chronic total occlusion (cto) in the patient's right anterior tibial (at) artery.During the procedure, the rep reported the spectranetics turbo elite could not cross the calcified lesion.When the device was removed from the patient, it was reported that the device's working length ''buckled'' and cracked the device's outer jacket, near where the physician was holding onto the device.A second device was used to complete the procedure.No user or patient harm was reported.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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9267998
• MDR Text Key: 196640181
• Report Number: 1721279-2019-00191
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)210805(10)FBD19G31A
• 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,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD19G31A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 75 YR