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

Model Number DBEC-125

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 3004742232-2018-00393.(b)(4).

Event Description

The tip of the diamondback coronary orbital atherectomy device 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 2.75 mm.

Manufacturer Narrative

Failure analysis conclusion: at the conclusion of the failure analysis investigation the event was confirmed.The device was returned to csi for analysis with a driveshaft fracture on the distal side of the crown weld.Driveshaft flexing at the weld location can initiate a fatigue failure, and scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, the exact root cause of this reported complaint is undetermined.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.This event occurred during the same procedure as described in mdr 3004742232-2018-00393.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: 8203939
• MDR Text Key: 131647961
• Report Number: 3004742232-2018-00392
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200630(10)230322
• 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: 06/30/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 230322
• 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