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

Model Number	414-151
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available from facility.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.Patient information not available from facility.Physician fax, phone and email not available from facility.Device has been requested for return but has not yet been received by manufacturer.
Event or Problem Description
A vascular intervention case commenced to treat the peripheral area.During the case a hydrophilic balance middleweight (bmw) microglide guide wire was used with a spectranetics turbo elite device and outer sheath.Before the procedure began, the philips representative attempted to advise the physician to not use the hydrophilic guide wire with the turbo elite device but the physician proceeded with using the hydrophilic guide wire.During the case the physician experienced difficulty advancing the laser catheter over the wire and decided to remove the turbo elite device from the patient.Once the catheter was removed, the physician observed melting and reported a ''burn'' mark on the outer sheath, near the middle of the working length.The philips representative also noticed a burn mark on the distal tip of the turbo elite catheter.Through out the procedure, the physician had flushed the catheter through the inner lumen between laser trains.The philips representative reported the guide wire had not had any damage.The turbo elite device was removed from the patient visibly whole and intact.The case was completed with another turbo elite device, and no patient injury was reported.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Additional Manufacturer Narrative
Correction for initial mdr: method code: on initial mdr, method code was listed as "10"; however device had not been returned for evaluation at that time.Method code should have been 4114 on the initial mdr.Additional information for follow up #1: method, results, and conclusions codes populated at this time.Device evaluation: the device was returned to the manufacturer on 29 april 2019 and evaluated on 2 may 2019.Wrinkles were present in the device's outer jacket and a breach to the outer jacket was confirmed 83 cm from the distal tip of the device.Simulated laser light confirmed broken fibers under the jacket.The device''s distal tip does not have any damage.Fluid flushed successfully through the inner lumen of the device, indicating no breach to the inner lumen.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8552910
• Report Number: 1721279-2019-00066
• Device Sequence Number: 2444032
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)201121(10)FAY18L15A
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019
• 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: 11/21/2020
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY18L15A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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
• Date Report Sent to FDA: 01/01/2005