MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Cardiovascular systems inc.Diamonback 360 orbital atherectomy system severed the viperwire advance® coronary guide wire during atherectomy.As a result, the distal 20mm of the viperwire fragmented into the distal right coronary artery.The clinical representative was present during the surgical procedure.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12318117
• MDR Text Key: 266396007
• Report Number: 12318117
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230228(10)368890
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 368890
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA