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

Model Number 423-135-02

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was unavailable from the site.Device has not yet been returned for evaluation.(b)(4).A 0.035 guidewire was used.A 0.018 or 0.014 may have achieved better results.Instructions for use for this device state: "note: depending on which approach is used, antegrade or contralateral, saline can be administered through the sheath (antegrade approach) or laser catheter inner lumen (contralateral approach).When the contralateral approach is used, smaller diameter guidewires are suggested to allow adequate saline infusion at the treatment site.".

Event Description

This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.A philips representative reported that a peripheral vascular atherectomy procedure commenced.A contralateral approach was used to reach the target lesion in the proximal popliteal.The vessel was semi-occluded, with in-stent restenosis and tortuous anatomy.At first, everything was going very well until the physician felt some resistance when attempting to advance the turbo-elite laser atherectomy catheter.The tip of the catheter was likely in contact with the stent.The doctor changed the guide-wire and tried again, at this point the shaft of the turbo-elite got very hot and it was possible to see some light coming out of it.The physician immediately removed the catheter and the contra-lateral sheath.It was possible to see that the heat melted the turbo-elite sheath and some parts of the shaft, also the tip of turbo-elite was not in the normal shape.Patient was indicated for limb amputation, after failure of the procedure, due to worsening of his clinical condition.

Manufacturer Narrative

The device was returned and evaluated on 27 june 2019 with a cross functional team.The entire working length of the catheter was inspected for damage starting at the distal tip of the catheter and inspecting proximal of the working length.At the distal tip of the device, distorted epoxy and biological material were noticed around the distal tip marker band.Fibers at the tip of the device showed signs of heavy use.This issue would be due to not enough hydration.At 95cm proximal of the tip, two wrinkles are noticed but there was no breach to the jacket.At 105cm proximal of the tip, distortion is noticed on the outside of the jacket.The catheter was plugged into a heme laser and inspected under the microscope to inspect for broken fibers and a breach to the jacket.Broken fibers are seen under the jacket but there was no breach to the jacket.The fibers most likely broke during use.At 108cm proximal of the tip, a twist in the jacket was noticed however there was no breach to the jacket.H6) device code was changed from 4008 and 1670 because during evaluation, the investigators concluded there was no breach to the jacket and no exposure to radiation.Device code was changed to 1670 because evaluation concluded the device was damaged during use.Patient code was changed from 3164 because during evaluation, the investigators concluded there was no breach to the jacket and no exposure to radiation.Patient code was changed to 3191 and 2692 because although there was a malfunction of the device, the device did not cause or contribute to the patient injury.Results code 114 was chosen because the evaluation concluded the device was damaged during use.Conclusions code 50 was chosen because although there was a malfunction of the device, the device did not cause or contribute to the patient injury.The device was used as a last effort to save the patients limb.After failure of the procedure, patient was indicated for limb amputation due to worsening of his clinical condition.

• 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: 8727880
• MDR Text Key: 148997511
• Report Number: 1721279-2019-00110
• Device Sequence Number: 1
• Product Code: MCW
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 423-135-02
• Device Catalogue Number: 423-135-02
• Device Lot Number: FBS19A31A
• Was Device Available for Evaluation?: 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: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035 GUIDEWIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; 0.035 GUIDEWIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 70 YR