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

Model Number	117-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Cardiac Perforation (2513)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient age unavailable.Patient weight unavailable.
Event or Problem Description
A coronary intervention procedure commenced to treat an in-stent restenosis (isr) on the left anterior descending coronary artery (lad), the left circumflex artery (lcx) opening and in the #13 atrioventricular groove of the lcx.Spectranetics ecla os and elca devices were in use during the procedure.While using the elca device, a perforation occurred on lcx #13.They treated the injury using a perfusion catheter and a graftmaster.Patient was transferred to the icu and survived.There was no reported malfunction of the spectranetics device used in the procedure.

• 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: 9709065
• Report Number: 1721279-2020-00034
• Device Sequence Number: 3319209
• Product Code: LPC
• UDI-Device Identifier: 00813132025427
• UDI-Public: (01)00813132025427(17)200315(10)FH318C09A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: 117-205
• Device Catalogue Number: 117-205
• Device Lot Number: FH318C09A
• Was Device Available for Evaluation?: No
• 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: 01/20/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 01/01/2005