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

Model Number DBEC-125

Device Problem Expulsion (2933)

Patient Problems Chest Pain (1776); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

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.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.(b)(4).

Event Description

Four atherectomy treatments were performed on low speed using a diamondback 360 coronary orbital atherectomy device (oad).The patient experienced st elevation, chest pain, and slow flow in the distal left anterior descending artery.Vasodilators, pain medication, and conscious sedation were administered.After approximately 15 minutes, the situation resolved.The oad was removed.Balloon angioplasty and stent placement were performed to complete the procedure.Following the procedure, the patient returned to pre-procedure condition and was discharged the same afternoon.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15020823
• MDR Text Key: 295949133
• Report Number: 3004742232-2022-00168
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568117
• UDI-Public: (01)10850026568117(17)240331(10)427490-1
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2022

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: 03/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-11
• Device Lot Number: 427490-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White