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

Model Number	420-159
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Occlusion (1984); Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Device evaluation: the turbo elite device was returned to the manufacturer and was evaluated on 28 january 2021 by a cross functional team.An obvious breach to the outer jacket was seen at the distal tip of the device.Damage was seen beginning 6cm from the device's distal tip, just distal to the port fuse, and extended distally towards the tip of the device.The outer jacket was bunched up and pulled over the device's distal tip.Multiple kinks were seen throughout the working length.These kinks spanned from distal tip to 60cm up the working length of the device.This has been determined to be a use related failure, occurring due to stresses placed on the device during its use within the patient.In conversations with the philips representative, she stated that the cook introducer sheath is a softer sheath as compared to others, and she stated she believed that the aortic bifurcation was tortuous, which may have contributed to the difficulty in removing the device from the sheath.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the patient's superficial femoral artery (sfa) using a contralateral approach.A spectranetics turbo elite laser atherectomy catheter and a 6f cook medical introducer sheath was used to treat this lesion.According to the report, the physician was able to complete a couple of long runs through the vasculature with pauses between the runs.After the atherectomy was completed and while the physician was removing`the turbo elite device from the patient's body, the device reportedly ''hung up'' within the sfa region before reaching the cook medical introducer sheath.After some effort, it was removed from the sfa but then got stuck in the introducer sheath.The device was able to be removed from the introducer sheath but the sheath had to be replaced afterward, and the size of the introducer sheath was increased due to bleeding.It was reported that the sfa lost flow during this time, and a balloon was used to re-obtain flow in the sfa.The procedure was completed with no reported patient harm.Visible damage to the turbo elite device was noted.The device was returned to the manufacturer and a device evaluation has been completed.In addition to the sfa losing flow in this procedure after use of the turbo elite 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
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11285113
• Report Number: 1721279-2021-00016
• Device Sequence Number: 4228881
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)220825(10)FBH20H14A
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH20H14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT 0.014 GUIDE WIRE; BALLOON MANUFACTURER UNKNOWN; COOK MEDICAL 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR