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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)

Event Date 04/28/2019

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 prior to distribution.The diamondback coronary orbital atherectomy system instructions for use manual states that arrhythmia and hypotension are potential adverse events that may occur and/or require intervention.(b)(4).

Event Description

Following three treatment passes of a heavily calcified lesion in the left anterior descending artery (lad) with a csi diamondback coronary orbital atherectomy device (oad), the patient became hypotensive and began to fibrillate.The oad was removed and a balloon pump was inserted for patient support.The patient entered cardiopulmonary arrest and cardiopulmonary resuscitation was performed, and a stent was placed in the lad.The patient stabilized and was discharged from the hospital one week later.Per the physician, the cause of the event was unknown, however the patient was unwell prior to the procedure and had a history of multi-vessel disease which may have contributed to the event.

• 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; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6512691600
• MDR Report Key: 8617152
• MDR Text Key: 145287206
• Report Number: 3004742232-2019-00138
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)201130(10)248573
• 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: 05/16/2019

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: 11/30/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 248573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• 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): Hospitalization; Required Intervention