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

Model Number	DBEC-125
Medical Device Problem Codes	Difficult to Remove (1528); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The csi field representative was aware of the event on (b)(6) 2018.The mdr is being reported after the 30 day due date due to an inadvertent failure to follow csi procedures.Retraining on the complaint reporting procedure has been issued.During the course of the investigation, it was determined that the device was available for evaluation.Csi requested return of the device on 24 september 2018 for the purpose of investigation, and the device was received at csi on 9 october 2018.Device evaluation: the oad was returned with the saline sheath, driveshaft and engaged guide wire having been destructively cut away from the handle assembly.The distal driveshaft and engaged guide wire exhibited adhered biological material on the tip bushing and guide wire core shaft in that area.The wire was removed with resistance and a mandrel would not pass through the biological material.The morphology of the biological material is not known, and the exact root cause of accumulating tissue remains unknown.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation.At the conclusion of the failure analysis investigation the reported events could not be confirmed through analysis.(b)(4).
Event or Problem Description
Medwatch (b)(4) was received by csi on 24 september 2018 which indicated the following: the stealth coronary orbital atherectomy device (oad) became stuck in a type c lesion in the proximal right coronary artery following three treatments at 80,000rpm.The speed was increased to 120,000rpm, but further attempts to remove the oad were unsuccessful.The device stopped spinning and was still stuck in the lesion.The viperwire and oad were removed from the patient.A dissection with no flow was identified.The patient reportedly experienced vomiting in relation to the event but was later discharged and was well upon discharge.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 7971140
• Report Number: 3004742232-2018-00306
• Device Sequence Number: 201431
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)200131(10)215019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 215019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/16/2018
• 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