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

Model Number 414-151

Device Problem Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A peripheral laser atherectomy procedure commenced.Patient information, indication for procedure, treatment location was requested but could not be obtained.The physician, per report, chose to use a spectranetics turbo elite laser atherectomy catheter for the procedure.It was reported that the device would not calibrate during preparation for use.It was also reported that a second device was used and the case was completed with no reported patient harm.When the complaint information was obtained, the lot number of the device revealed that the device which would not calibrate had expired.This report is being created due to the potential for complication if this event was to recur and the device would have been used within the patient.

Manufacturer Narrative

H6): added codes: 4755 and 2199.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11595883
• MDR Text Key: 265156975
• Report Number: 1721279-2021-00047
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)210108(10)FAY18M27A
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY18M27A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TURBO ELITE LASER CATHETER
• Patient Outcome(s): Other