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

Model Number GWC-12325LG-FLP

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was returned along with the oad used during the procedure.A visual examination found the spring tip of the guide wire to be detached and missing.There was no other damage observed with the guide wire or oad.Scanning electron microscopy was performed on the oad tip bushing and did not find any evidence that the tip bushing had come into contact with the guide wire spring tip.When tested, the oad functioned as intended with no anomalies noted.At the conclusion of the device analysis investigation, the reported wire detachment was confirmed.However, the root cause of the detachment could not be conclusively 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.(b)(4).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), the tip of the guide wire became detached.The target lesion was located in the left main and was treated using two passes with the oad.The oad was unable to be advanced further and was found to be stuck on the guide wire.The device was removed from the body, however the guide wire was difficult to remove.The guide wire was removed with the guide catheter and the tip of the wire was found to have become detached inside the patient.The wire fragment was located in the profunda and groin access was gained to snare the wire.During removal, the wire fragment broke in half and one portion of the wire was removed with a snare.The second portion of the wire fragment remained in the patient.The patient was in stable condition following the procedure.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7583713
• MDR Text Key: 110532259
• Report Number: 3004742232-2018-00164
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)191031(10)10930847
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 10930847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 83 YR