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

Model Number	410-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age unavailable.Patient weight unavailable.Device evaluation: the device was returned and evaluated by a cross functional team on 02 july 2020.Visually, the team initially observed damage located 65cm proximal of distal tip.In this area, the device's outer jacket appeared twisted and wrinkled.There was no breach to the jacket in this area.Additionally, the team confirmed that an area of the device's outer jacket appeared to be stretched.Beginning at the area of this stretched outer jacket damage, the distal portion of the device had separated.Approximately 9.5cm of outer jacket and fibers were separated, and 8.7cm of inner lumen was separated from the distal portion of the device.Follow up information from the philips representative confirmed there was heavy calcification in this area causing difficulty while advancing the device.The team could not confirm how the damage was caused to the catheter.
Event or Problem Description
A peripheral vascular intervention procedure commenced to treat a severely calcified lesion in the patient's distal posterior tibial artery using an ipsilateral approach (access to the lesion was performed on the same side of the body as the location of the lesion).Using a spectranetics turbo elite laser atherectomy catheter, the physician was able to access the lesion.Upon the second insertion of the device to treat the lesion, when the device was removed from the patient's body, it was reported that the tip of the laser broke off.The tip remained in the patient's body and was not removed at the time of the procedure (details unknown).It was reported that there was resistance upon advancement of the device within the vasculature and that there was no other device used simultaneously during the use of the turbo elite device.It was believed, per report, that the patient was going to see a vascular surgeon for additional treatment since they were unsuccessful at treating the lesion during this procedure.The patient survived the procedure.This event is also being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation resulting from the device damage.

• 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: 10261467
• Report Number: 1721279-2020-00138
• Device Sequence Number: 2624191
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)220317(10)FBD20B21A
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 06/16/2020
• Report Date (Section F): 01/01/2005

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: 03/17/2022
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD20B21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005