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

Model Number	410-154
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable, although requested.The manufacturer is anticipating return of the device for evaluation but has not received it at this time.(b)(4).
Event or Problem Description
A philips representative became aware that on 23 mar 2021, a peripheral atherectomy procedure commenced.Patient and case details are unavailable, although requested.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that during use in the procedure, it was noted that there was a hole in the side of the device.The procedure was reportedly completed with a second device, with no reported patient harm.From the information obtained, this report is being submitted due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The manufacturer is anticipating return of the turbo elite device for evaluation, but has not received it at this time.
Additional Manufacturer Narrative
H3): the manufacturer had anticipated return of the device for evaluation.However, the manufacturer received information via email on (b)(6) 2021 that the facility no longer has possession of the device.Since the device has not been returned, no investigation can be completed.H6): added codes: 772, 2199, 4114, 3221, and 4315.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 20 july 2021.G3): the device was evaluated by the manufacturer on 29 july 2021.H3): the device evaluation and investigation were completed.H6): added component code 814; component code 772 remains applicable to the event.H6): added codes 10, 3243, and 61.Device evaluation: the device was returned and evaluated by a cross functional team.A breach to outer jacket was identified 3.5cm from the device''s distal tip.One dead fiber was confirmed in the area of the breach.The device was taken to the failure analysis lab to identify how the breach occurred.The failure analysis lab believes the breach was a mechanically induced failure by externally puncturing the outer jacket with small object inserted from distal side and moving proximal.The failure was confirmed by recreating the failure (failure simulation) using a probe on another point of the outer jacket.The damage observed during failure simulation looked similar to the breach observed per the reported complaint.This failure has been determined to be use related.

• 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: 11689802
• Report Number: 1721279-2021-00066
• Device Sequence Number: 14198314
• Product Code: MCW
• UDI-Device Identifier: 00813132024703
• UDI-Public: (01)00813132024703(17)230215(10)FBE21B03A
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2021

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: 02/15/2023
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE21B03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 07/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/16/2021; 08/13/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other