MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEM, INC. DIAMOND BACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ARTHERECTOMY

Model Number DBEC125

Device Problem Peeled/Delaminated (1454)

Patient Problem Perforation of Vessels (2135)

Event Date 08/13/2018

Event Type  Injury  

Event Description

During advancement of viperwire for angioplasty, while performing a 2nd drilling, it was identified by the physician that the orbital atherectomy device had advanced after the 1st deactivation.The device was pulled back, but the tip of the wire was sheared off.It appeared that the viper wire had perforated the vessel.The pt required being transferred to another facility for surgical removal of wire tip via coronary bypass procedure.

• Brand Name: DIAMOND BACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ARTHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEM, INC. ; st. paul MN
• MDR Report Key: 7805585
• MDR Text Key: 118018044
• Report Number: MW5079301
• Device Sequence Number: 2
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/16/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: DBEC125
• Device Catalogue Number: 70058-02
• Device Lot Number: 213759
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Weight: 28