MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

Model Number DBE-200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 07/03/2014

Event Type  Injury  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a dissection occurred that was resolved using an unplanned stent.The target lesion was located in the superficial femoral artery (sfa).The physician used a csi viperwire guide wire and csi orbital atherectomy device (oad) to treat the lesion.The physician successfully completed two runs in the lesion, but during the third run, the device stopped running and would not start again.A dissection was noted, so the physician removed the viperwire guide wire and oad as a unit and re-wired the lesion.The physician resolved the dissection via balloon angioplasty and stent placement.The patient status remained stable throughout the procedure.Requests for additional information have been made, but none has yet been received.

Manufacturer Narrative

Device analysis: the device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The device history record for this oad 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).

• Brand Name: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3966619
• MDR Text Key: 4612167
• Report Number: 3004742232-2014-00039
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: DBE-200
• Device Catalogue Number: DBE-200
• Device Lot Number: 97007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2014
• 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