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

Model Number 423-050

Device Problems Material Perforation (2205); Material Deformation (2976)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

The site did not wish to provide patient information.It was reported that the turbo power device was curved on about half of the catheter, appearing as if it had memory to the shape of the package.Upon attempt to load catheter onto wire, the turbo power would not easily advance and had a lot of drag.The device reportedly never entered the patient's body.The case was completed with use of another turbo power with no reported patient harm.The device was returned and evaluated.Upon visual inspection, outer jacket had a noticeable bend 41 cm from distal tip and was leaking fluid.12cm proximal of the scuff mark: jacket felt "crusty" when flexed.Device was fully patent when passing a 0.018 guide wire through the lumen.The bent area and scuff mark were evaluated; outer jacket coating was noticed around fibers.Water was added and fibers became slick - confirming that coating was present inside the jacket and on the fibers.Production process issue confirmed; outer jacket damage.Outer jacket coating entered into the catheter through scuff in the outer jacket.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

Event Description

On 18dec2018: a philips representative reported that during a peripheral atherectomy procedure to treat an 80 percent stenosed diffusely diseased superficial femoral artery (sfa).It was decided to treat the lesion with a spectranetics 2.3 turbo-power laser atherectomy catheter 423-050.It was noted upon removing the turbo power from the packaging that it had a curve on about half of the catheter.It appeared the shape was set as the device had been in the package.They flushed and attempted to load the catheter on the guidewire.Upon loading the turbo power onto a.018 sv5 wire, the turbo-power device would not easily advance forward and had a lot of drag.The device never entered the guide sheath or the patient's body.A new turbo power was opened and the patient was successfully treated without incident.On 07feb2019: during evaluation of the suspect turbo-power device, it was detected under microscopic evaluation, that the turbo-power had a breach in the outer jacket.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-POWER LASER ATHERECTOMY CATHETER
• Type of Device: TURBO-POWER
• 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: 8376255
• MDR Text Key: 141079558
• Report Number: 1721279-2019-00026
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K180694
• 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: 01/01/2005,12/18/2018

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: 07/05/2020
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: FMP18F25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• 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
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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