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

Model Number DBEC-125

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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.Csi id# (b)(4).

Event Description

During a procedure with a diamondback coronary orbital atherectomy device (oad), a perforation occurred.The three 75% stenosed, calcified, nodular target lesions were located in an area of the proximal to mid right coronary artery (rca) that was 3.00 mm in diameter.Four smaller balloons were used to help the ivus cross the lesions, and treatment was subsequently started.The lesions were treated in a proximal to distal order with the orbital atherectomy treatment of each lesion being performed in a distal to proximal direction.When the second lesion was being treated, the physician mistook the adventitia for a side branch, performed additional spinning and a perforation of the myocardial side of the vessel occurred.A covered stent was implanted to treat the perforation.The patient's condition was good 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 9295524
• MDR Text Key: 165577416
• Report Number: 3004742232-2019-00281
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005794
• UDI-Public: (01)10852528005794(17)210430(10)269298
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: DBEC-125
• Device Lot Number: 269298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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: 79 YR