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

Model Number 110-004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 09/25/2018

Event Type  Injury  

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 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.

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
• Type of Device: ELCA
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7976271
• MDR Text Key: 124070693
• Report Number: 1721279-2018-00148
• Device Sequence Number: 1
• Product Code: LPC
• UDI-Device Identifier: 00813132020033
• UDI-Public: 00813132020033
• Combination Product (y/n): Y
• PMA/PMN Number: P910001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention