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

Model Number	420-159
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information available.Device evaluation: the device was returned to the manufacturer and evaluated on 16 january 2020.During the evaluation a breach was seen to the device's outer jacket, approximately 2cm from the device's distal tip.After attempting to insert a guide wire through the device's inner lumen, resistance was felt at 2cm from distal tip, the same location as the breach.The inner lumen of the device was confirmed not patent.Inspection of the inner lumen showed it to be prolapsed, where the breach was detected.It is likely that the guide wire was the cause of the breach, coming from inside the lumen at the area of prolapse, out through the outer jacket.The team could not determine when the breach occurred.
Event or Problem Description
A peripheral vascular intervention procedure commenced due to the patient having vascular disease.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.The initial report received by the manufacturer was that the guide wire would not pass through the wire lumen.The procedure was completed with another device and there was no reported patient harm.However, when the device was returned to the manufacturer for evaluation, the device was found to have a breach in the device's outer jacket.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: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9688397
• Report Number: 1721279-2020-00029
• Device Sequence Number: 3474763
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)211106(10)FBH19L04A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH19L04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• 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: 01/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005