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

Model Number	420-159
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unavailable, although multiple requests for this information have been made the manufacturer is anticipating the return of the turbo elite device for evaluation, but it has not been received at this time.(b)(4).
Event or Problem Description
A philips representative became aware on 19 nov 2020 that a peripheral atherectomy procedure occurred on (b)(6) 2020 and a spectranetics turbo elite laser atherectomy catheter was used (the representative was not present at the procedure; the information was reported by the facility/physician).Indication for and location of the procedure is unknown.Requests for additional information have been made but no further information has been obtained.During use in the patient, the device's marker band became detached while in the patent's body.The physician attempted to use a balloon to retrieve the marker band but was unsuccessful; the band remained inside the body and was unable to be removed.The patient survived the procedure.The manufacturer is anticipating the return of the turbo elite device back for evaluation, but has not received it at this time.
Additional Manufacturer Narrative
D10): device was returned to manufacturer on 22 dec 2020.H3): fields populated since device was returned to and evaluated by manufacturer.H6): patient, method, results and conclusions codes now populated after device evaluation is complete.Device evaluation: the turbo elite device was returned to the manufacturer and was evaluated by a cross functional team, with the investigation completed on (b)(6) 2021.Despite the information received initially and submitted in the initial mdr (which was that the device's distal marker band had detached and remained in the patient), the device's marker band was found to still be present on the distal tip of the device.The epoxy, present on the device's distal tip, was eroded.With the erosion removed, the distal marker band had moved forward (from distal portion of the device to the distal tip of the device).There was no other damage present the entire length of the device.This has been determined to be a use related failure.Historically, this type of damage has been seen when the device is activated without clearing contrast from the treatment site, or when the device is used without adequate hydration/flushing being performed.Even though the marker band had not detached from the device in this event, it did move from its original location on the device due to epoxy erosion.This event remains reportable due to the potential for serious injury with recurrence.On 25 jan 2021, a phone call between the manufacturer and the facility representative noted that the procedure was completed successfully with an ivus catheter, atherectomy and a balloon.Since the marker band was present on the device and returned to the manufacturer, questions were asked of the facility representative to seek answers as to what the physician saw on fluoroscopy images, as well.A response from the representative was received on 08 feb 2021.The guidewire used in the procedure was reportedly removed in its entirety and no damage to the guidewire was noted.The facility representative stated that she didn't remember whether the device's tip was inspected after the procedure; she stated the structure noted within the patient was seen soon after withdrawal of the device and it appeared as a ring with the diameter of the device's tip.It was reported it was pushed to the lateral wall of the stent with a balloon.Lastly, on 11 feb 2021, (b)(6), medical affairs was consulted and the fluoroscopic images were reviewed.He stated: "based on the two still frame images.And the fact that no parts of the laser catheter were missing on the engineers report, i can conclude that the staining noted on the second image is retained contrast in part of the plaque behind/around the stent.The distal marker of the laser catheter is clearly seen on the pic and the radio-opaque irregularity does not look like a catheter tip anyway".This event 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: 11020606
• Report Number: 1721279-2020-00254
• Device Sequence Number: 3813464
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)220825(10)FBH20H14A
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH20H14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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: Required Intervention