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

Model Number	420-159
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated on 06 may 2021 by a cross functional team.Obvious damage seen to outer jacket running from port to 8.7cm from distal tip.In the area of the broken outer jacket, there are exposed and broken fibers present.The inner lumen had kinks seen in the area of the broken outer jacket, but otherwise intact.This failure has been determined to have occurred during use of the device due to no manufacturing or design issues noted when the device was released for distribution, and historically this failure mode has been seen when the guide wire is forced in an opposite direction of the catheter causing the inner lumen to pull away at the port, causing a tear in outer jacket.The component code and health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter component codes (b)(4).
Event or Problem Description
A philips representative became aware on 21 apr 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat a slightly calcified fibrous lesion in the patient's proximal superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.According to the physician, the device reportedly "basically fell apart" as soon as it was removed from the package.It was reported that the outer sheath covering the device's fibers was town, just distal to the device's rx wire exchange port.The physician stated to the philips rep that they noticed the problem before it went into the patient, as they were prepping the device.The procedure was completed successfully with a second device with no reported patient injury.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The device was returned to the manufacturer for evaluation and the device evaluation is present.
Additional Manufacturer Narrative
H6): added codes: 772, 814, and 2199.

• 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: 11845805
• Report Number: 1721279-2021-00091
• Device Sequence Number: 3869605
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)230201(10)FBH21A19A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/21/2021

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: 02/01/2023
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH21A19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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: SECOND DEVICE TO COMPLETE PROCEDURE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other