MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (GUIDE WIRE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226); Foreign Body In Patient (2687)

Event Date 03/18/2023

Event Type  Injury  

Event Description

During a low speed treatment in a heavily calcified 70% left anterior descending artery, the viperwire guide wire became fractured which resulted in a perforation.The patient's blood pressure decreased.Pericardiocentesis was performed due to cardiac tamponade.Stent placement was performed to cover the perforation.The fractured component remained in vivo.The patient was stable.

Manufacturer Narrative

The material inspection report for this guidewire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.3004742232-2023-00124 investigation conclusion code (b)(4): the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels and cardiac/pericardial tamponade are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (GUIDE WIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN
• MDR Report Key: 16904807
• MDR Text Key: 314933710
• Report Number: 3004742232-2023-00124
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568391
• UDI-Public: (01)10850026568391(17)240131(10)416965-1
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 416965-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male