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

Model Number	110-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age and weight were requested, but unavailable from the site.Device lot # was requested, but was unavailable from the site as the device was discarded.The expiration date cannot be determined without a lot#.Device manufactured date cannot be determined without the lot#.The device was discarded by the site.There is no allegation that a malfunction of the device caused or contributed to the reported event.
Event or Problem Description
A philips representative reported that during a coronary laser atherectomy procedure for a chronic total occlusion of the circumflex artery, the physician was unable to advance through the lesion (balloons, etc., would not work).The physician began lasing with the elca coronary laser atherectomy catheter 110-004.An artery was perforated.The physician attempted to stop the bleeding with a balloon, but could not.The patient was transferred to the operating room for repair of the injury.Physician was unsure what caused the artery perforation.The patient's status has been requested from the site, but no information has been provided other than what is contained herein.
Additional Manufacturer Narrative
On (b)(6) 2018 it was reported by a philips representative that the patient passed away on (b)(6) 2018.

• 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: 7976271
• Report Number: 1721279-2018-00148
• Device Sequence Number: 16537078
• Product Code: LPC
• UDI-Device Identifier: 00813132020033
• UDI-Public: 00813132020033
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/25/2018
• 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 Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 10/23/2018
• 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
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 01/01/2005