MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER

Model Number	117-016
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.Manufacturer has been informed that this device will be returned for evaluation but has not been received at this time.Due to covid-19 crisis, the device return may be significantly delayed.
Event or Problem Description
A coronary vascular intervention procedure commenced to treat in stent restenosis (isr) within the patient's proximal circumflex artery.The physician chose a 1.7f spectranetics elca coronary atherectomy catheter to treat the patient.During the procedure, the device's distal marker band detached within the coronary artery.The physician was able to inflate a balloon, retrieved the marker band and removed it from the body.There was no harm reported to the patient.The manufacturer has been informed the device is being returned for evaluation; however it has not been received at this time.Due to covid-19 crisis, the device return may be significantly delayed.
Additional Manufacturer Narrative
D10): device returned to manufacturer on 29 june 2020.H3): device returned to manufacturer and device evaluation completed.H6): method, results and conclusions codes populated after device evaluation completed.Device evaluation: the device was returned on 29 june 2020 and evaluated on 02 july 2020 with a cross functional team.The balloon that was used to retrieve the marker band was also returned with the marker band still attached to the balloon.During visual inspection, the team observed scratches and marks on the marker band.The team also confirmed the band had broken horizontally.The break had allowed the band to slide off the tip of the catheter and was the cause of the experienced failure.During visual inspection of the device, there was no damage identified except fibers were slightly protruding from the tip.Follow up from information from the philips representative explained that the physician may have been lasing in the presence of contrast during the case.In the spectranetics instructions for use (ifu) for the elca device, 12.2, 8.B., it states: "flush all residual contrast media from the lasing site and vascular structures adjacent tot he lasing site, prior to activating the cvx-300 laser system.".

• Brand Name: SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER
• Common Device Name: ELCA
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9935985
• Report Number: 1721279-2020-00091
• Device Sequence Number: 16768412
• Product Code: LPC
• UDI-Device Identifier: 00813132020057
• UDI-Public: 00813132020057
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910001
• 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): 03/19/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 117-016
• Device Catalogue Number: 117-016
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82
• Date Report Sent to FDA: 01/01/2005