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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.The event for the oad used in this procedure was reported under mdr 3004742232-2020 00422.(b)(4).

Event Description

Orbital atherectomy was administered for three treatment passes on low speed in the left circumflex artery and during attempts to remove the oad, the crown became stuck in the vessel.The viperwire guide wire was able to be pulled backward, however the oad remained stuck.A snare device was inserted, however the snare, oad driveshaft and the viperwire guide wire fractured.The patient was transferred to the hospital and an additional snare device was inserted in an attempt to retrieve the fragments, however it was also unsuccessful.A surgical procedure was performed and all components were removed from the patient.

Manufacturer Narrative

The reported guide wire was received at csi, engaged in the oad.Visual examination confirmed the guide wire was fractured, proximal to the proximal solder bond, and that the fractured spring tip was wrapped around the oad driveshaft.The proximal end of the guide wire was confirmed to have been cut.Scanning electron microscopy analysis revealed damage to the proximal spring tip solder bond and evidence of tensile failure on the fracture face.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed.It was hypothesized that the cause of the fracture was due to tensile forces likely applied during removal attempts, however this could not be confirmed, and the root cause was undetermined.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: 09480.

• 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: 11078129
• MDR Text Key: 223801125
• Report Number: 3004742232-2020-00423
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)220331(10)315682
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 315682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR