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

Model Number WC-12325LG-FLP

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.This event occurred during the same procedure described in mdr 3004742232-2018-00392.(b)(4).

Event Description

The tip of the viperwire fractured in the left anterior descending artery during the procedure.The fragments were removed surgically.The patient was well following the procedure and was recovering as of (b)(6) 2018.The lad was reportedly 95% stenotic with vessel diameter of 2.5 to 2.75mm.

Manufacturer Narrative

Failure analysis conclusion: at the conclusion of the failure analysis investigation the reported event was confirmed.The viperwire was returned to csi for analysis, but the distal fractured guide wire section was not returned for analysis.Scanning electron microscopy analysis of the guide wire fracture face revealed necking and shear dimples.This indicates that the guide wire core underwent a tensile force fracture.As the original oad driveshaft fractured distal portion and the guide wire spring tip section were not returned for analysis, the root cause of the necking, shear dimples and ultimately the spring tip and core wire section separating from the guide wire is undetermined.The device history record for this viperwire 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.This event occurred during the same procedure described in mdr 3004742232-2018-00392.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8204026
• MDR Text Key: 131646640
• Report Number: 3004742232-2018-00393
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005187
• UDI-Public: (01)30852528005187(17)200131(10)10971163
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• 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: 01/29/2019

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: 01/31/2020
• Device Model Number: WC-12325LG-FLP
• Device Lot Number: 10971163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 70