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 Code	Radiation Exposure, Unintended (3164)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable, although requested.Device evaluation: the device was returned and evaluated on 15 october 2020 by a cross functional team.The distal tip and marker band were in good working condition.The device was returned with no portions of the device missing.A 0.014 guide wire was fed through the distal end, and resistance was felt underneath the bifurcate cover.While loading that same guide wire through the proximal bifurcate the guide wire felt resistance 10.5cm from the distal tip.This resistance was from biologics located within the inner lumen.At 10cm from distal tip a breach in the outer jacket was identified.In this area, fibers were exposed but no broken fibers were seen.Using a 60cc syringe attached to the bifurcate, water was used to flush the inner lumen.Water was seen exiting out the breach located 10cm from the distal tip.This confirmed a breach in the inner lumen and outer jacket.This is a confirmed use related failure.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Event or Problem Description
A peripheral atherectomy procedure commenced, using a spectranetics turbo elite laser atherectomy catheter.Patient information and case detail were requested, but minimal information was provided (the philips representative was not present at the procedure, and the information was obtained via the facility/physician to the rep).It was reported that the device tip broke off, but not inside the patient; instead it reportedly broke off upon removal of the device.There was no reported embolism.The case was reportedly completed with other products, with no reported harm to the patient.Additional information obtained during the manufacturer's device evaluation occurring 15 oct 2020 confirmed there was no device tip break and no portion of the device had detached; instead, a breach in the device's outer jacket was discovered.Additional device evaluation information is present.This report is being submitted 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: 10692216
• Report Number: 1721279-2020-00214
• Device Sequence Number: 304601
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)220604(10)FBD20E26A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD20E26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other