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

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

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Nausea (1970)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of samples of the same lot of the reported device is in progress by the original manufacturer.A supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).

Event Description

The patient experienced shaking, chills, shortness of breath, fever, agitation and nausea approximately 10 minutes after atherectomy treatment.The opinion of the physician was that the symptoms were caused from a reaction to the viperslide lubricant.Antihistamines, steroids, iv fluids, and oxygen were administered, and the patient was admitted to the hospital.

Manufacturer Narrative

The investigation of this product was performed by the original manufacturer, fresenius kabi.Fresenius kabi provided the following analysis conclusion: ten samples of the lot numbers 10nl2942 and 10ni1261 were received for the evaluation of this event.It was unknown which lot number was used during the event.The samples were unable to be investigated as it was unknown if unfulfilled environmental requirements or customer handling may have affected the packages.The certificate of conformity for both lot numbers indicates no anomalies; all test results were within limits and in conformance with valid specifications.The two batches are manufactured according to gmp guidelines.There were no deviations reported during production and quality control of the batches.These batches met all specification requirements.Lot number information: 10nl2942: (01)30852528005125(17)211031(10)10nl2942; manufacture date: 11/13/2019; 10ni1261: (01)30852528005125(17)210831(10)10ni1261; manufacture date: 9/26/2019.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 11720572
• MDR Text Key: 247687013
• Report Number: 3004742232-2021-00147
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 78