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

Model Number 420-006

Device Problem Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Radiation Exposure, Unintended (3164)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

The physician in this procedure was male.Patient information not obtained for this event; there is no reported patient harm.

Event Description

A peripheral vascular intervention commenced to treat a lesion in the patient's superficial femoral artery (sfa).During use of the spectranetics turbo elite device, it was reported that the physician felt a sensation which felt warm through his glove.He expressed discomfort in his finger.The location of this occurrence was reportedly where the physician's fingers were placed while the device was in use, outside of the patient's body.It was believed that the physician's glove remained intact, and it was reported that no first aid or intervention was required for this area on the physician's finger.The procedure was completed with the device and the patient survived the procedure.In addition, due to the description of the event reported to the manufacturer, this event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation, in the event that the device was broken.The manufacturer is anticipating the return of the device for evaluation but has not yet arrived at the manufacturer.

Manufacturer Narrative

Device was returned to manufacturer on 02 dec 2019.Device evaluation performed.Patient code 3164: in the initial mdr, code 3164 was used.After device evaluation, it was confirmed that there was no potential for exposure to manufacturing materials nor unintended radiation exposure.Code no longer appropriate in this event.Method, results and conclusions codes now populated based on results of device evaluation.Device evaluation: the device evaluation was performed and completed by a cross functional engineering team on 05 dec 2019.Visual inspection of the device confirmed no damage to the catheter.The catheter was plugged into simulated laser light; no breach of the device jacket was seen.Under the microscope, white residue is seen on the catheter at 78cm (unknown substance, however this residue would not cause harm to the physician).Again confirmed there was no breach to the jacket.The evaluation could not determine the cause of the experienced failure.Due to no malfunction being present for this turbo elite device, this is no longer a reportable event.

• 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
• MDR Report Key: 9366094
• MDR Text Key: 194398914
• Report Number: 1721279-2019-00207
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)210718(10)FBA19G16A
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA19G16A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• 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: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1