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

Model Number DBEC-125M

Device Problems Off-Label Use (1494); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

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.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.The "diamondback 360 coronary orbital atherectomy system micro crown instructions for use" manual states that use of the oas is contraindicated when the target lesion is within a bypass graft or stent.(b)(4).

Event Description

The diamondback coronary orbital atherectomy device (oad) was used off-label to treat a coronary lesion in a pre-existing stent; this resulted in the stent becoming wrapped around the crown of the oad.The oad was removed from the patient, and the procedure was completed with non-csi atherectomy and a stent with no additional complications.The patient prognosis was good.Additional information was requested, but the physician declined to respond.

Manufacturer Narrative

Csi id# (b)(4).

Event Description

The diamondback coronary orbital atherectomy device (oad) was used on low and high speeds off-label to treat a lesion in a pre-existing, underexpanded stent in the left anterior descending coronary artery (lad); this resulted in the stent becoming wrapped around the crown of the oad.The oad and stent were removed from the patient, and the procedure was completed with non-csi atherectomy and a stent with no additional complications.The patient prognosis was good.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8408762
• MDR Text Key: 138432694
• Report Number: 3004742232-2019-00071
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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 Model Number: DBEC-125M
• Device Catalogue Number: 7-10000-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR