MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360, ORBITAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problem Break (1069)

Patient Problems Intimal Dissection (1333); Perforation (2001)

Event Date 11/04/2020

Event Type  Injury  

Event Description

Pt underwent left heart catheterization with coronary angiography, left ventriculography, mid circumflex orbital atherectomy, ptca with intra coronary stent implantation and first obtuse marginal artery orbital atherectomy ptca with intracoronary stent implantation.During the procedure, the wire was removed, however the tip of the nitinol wire broke inside the coronary artery.Multiple attempts were made to retrieve the tip of the wire which were eventually successful with a 2.0 mm snare.However, a dissection and perforation were noted.Interventional radiologist then deployed several coils.An echocardiogram showed normal left ventricular systolic function with an lvef of 65% and no significant pericardia.Effusion and a pericardia.Fat pad was seen at the anterior wall.

• Brand Name: DIAMONDBACK 360, ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED ; 1225 old hwy #8 nw; st. paul MN 55112
• MDR Report Key: 10875557
• MDR Text Key: 217688871
• Report Number: MW5098005
• Device Sequence Number: 1
• Product Code: MCX
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DBEC-125
• Device Lot Number: 337441-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71