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

Model Number VPR-SLD2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

The investigation of this product was performed by the original manufacturer, fresenius kabi.Fresenius kabi provided the following analysis conclusion: no sample was received for the evaluation.A stability study review did not show any deviating or long-term trends approaching limits.Product quality conforms to the population norm.A batch review cannot be performed without a batch number.Csi id: (b)(4).

Event Description

During treatment in the left anterior descending artery with a diamondback coronary orbital atherectomy device (oad), the systolic blood pressure of the patient fell below 90 with no significant st changes.Noradrenaline was administered, but there was no improvement.Treatment with the oad was stopped and the procedure was completed with use of a drug coated balloon.Directly after the procedure, the patient presented with a red rash on their trunk.Allergy tests for glycerin, egg yolk and egg white were conducted for the patient and were negative.The rash was not present at the sheath introducer insertion site and the physician did not believe the reaction was related to ethylene oxide.The patient had undergone prior procedures in the past with no prior contrast allergy.The rash resolved without additional intervention and the condition of the patient was good as of (b)(6) 2021.

• 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; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 11957285
• MDR Text Key: 255091179
• Report Number: 3004742232-2021-00202
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: VPR-SLD2
• Device Catalogue Number: 72031-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 62 YR