MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEM INC. CSI DIAMONDBACK 360 CORONARY CLASSIC ATHERECTOMY SYSTEM; OAS DIAMONDBACK 360 CORONARY CLASSIC GUIDEWIRE

Model Number 1.25 CLASSIC

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Death (1802)

Event Date 03/09/2018

Event Type  Death  

Event Description

Csi - oas diamondback 360 coronary classic guidewire lot # 191513 broke during procedure and was unable to be retrieved resulting in patient requiring open heart surgery.Catheter inserted by guidewire, left coronary system injected and multiple views taken.Wire exchanged for a pt2x300 over a 1.5x20 balloon, rt2 inserted into the circumflex, coronary artery visualized, interventional wire removed, interventional guidewire inserted.Pt2x300 reinserted, interventional wire removed, interventional guidewire reinserted, viperwire reinserted, coronary artery visualized, ptca balloon removed, coronary artery visualized, viperwire sheared and distal piece of wire remains in circumflex artery.Dates of use: (b)(6) 2018.Diagnosis or reason for use: cardiac artery disease (70 percent distal left main, 80 percent circ).

• Brand Name: CSI DIAMONDBACK 360 CORONARY CLASSIC ATHERECTOMY SYSTEM
• Type of Device: OAS DIAMONDBACK 360 CORONARY CLASSIC GUIDEWIRE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEM INC. ; st. paul MN
• MDR Report Key: 7365064
• MDR Text Key: 103346884
• Report Number: MW5075979
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 1.25 CLASSIC
• Device Lot Number: 191513
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Death
• Patient Age: 81 YR
• Patient Weight: 35