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

Model Number 420-159

Device Problem Fracture (1260)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information is unavailable.

Event Description

It was reported to the manufacturer that a peripheral atherectomy procedure commenced.The physician chose a spectranetics turbo elite device to use in the procedure.The physician attempted to insert, and subsequently encountered difficulty advancing the device into the outer sheath.When the physician pulled the device out of the outer sheath, it was observed that the turbo elite device's outer jacket was breached and fibers were exposed.Another device was used to complete the procedure with no reported patient harm.The device reportedly did not enter the patient, nor was lasing attempted with the device.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: 9445531
• MDR Text Key: 194398565
• Report Number: 1721279-2019-00211
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)211021(10)FBH19K18A
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH19K18A
• 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: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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