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

Model Number	114-009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Iatrogenic Source (2498)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth unavailable.The elca device was returned to the manufacturer and evaluated on (b)(6) 2019.Pictures of device tip: no damaged epoxy and only one dead fiber was present.Pictures of marker band: no damage detected to the distal tip marker band.This event is determined to be use related as physician was lasing in contrast medium, and the ifu for the elca device, 12.2 clinical technique, 8.B., states: flush all residual contrast media from the lasing site and vascular structures adjacent to the lasing site, prior to activating the cvx-300 laser system.
Event or Problem Description
During a coronary vascular intervention procedure to treat a slightly calcified plaque lesion within the mid left anterior descending (lad) artery, a spectranetics elca device was in use.During use, the device''s marker band reportedly detached from the device.Physician was lasing in contrast medium when the event occurred.The device's marker band was retrieved with balloon.A balloon was used to complete the procedure with no reported patient harm.

• Brand Name: SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
• Common Device Name: ELCA
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8662864
• Report Number: 1721279-2019-00093
• Device Sequence Number: 2130760
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)210408(10)FH110D04A
• 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
• Report Date (Section B): 05/13/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH119D04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• 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: 05/10/2019
• Initial Report FDA Received Date: 06/03/2019
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 64
• Date Report Sent to FDA: 01/01/2005