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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Dr.(b)(6) assisted with the procedure after the guide wire fractured.Csi id: (b)(4).
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was used to successfully treat a lesion located on the mid-distal section of the circumflex artery.The oad was removed, and the viperwire guide wire was left in vivo for stent placement.Following stent placement, a balloon was inserted, and was unable to track over the wire.Imaging revealed that the wire was no longer in the vessel, and when the wire was pulled backward the spring tip of the guide wire remained in place.Multiple unsuccessful attempts with angioplasty balloons and a non-csi guide catheter were made to retrieve the fragment.Three guide wires were then inserted to surround the fragment, and it was successfully retrieved from the patient's body.The patient was discharged and doing well.
Additional Manufacturer Narrative
The reported guide wire was returned at csi for analysis, without the spring tip.Visual examination confirmed a fracture on the core shaft.Scanning electron microscopy of the guide wire revealed evidence of torsional dimples and rotational wear near the fracture.The surface wear was the result of use in an elevated stress environment and was consistent with the oad spinning in a tight bend, but not traversing, resulting in excessive wear on the guide wire.At the conclusion of the device analysis investigation, the reported event was confirmed, however the root cause could not be determined.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: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10196892
• Report Number: 3004742232-2020-00177
• Device Sequence Number: 16760297
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210430(10)11100502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11100502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 111