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

Model Number DBEC-125

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2018

Event Type  Injury  

Event Description

The clinical event committee reviewed procedural images and concluded that the diamondback 360 coronary orbital atherectomy device may have contributed to myocardial infarction.No further information is available.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that myocardial infarction is a potential adverse event that may occur and/or require intervention with use of the system.The device history record for the reported oad could not be reviewed as the lot number was not provided.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.Csi id: (b)(4).

Event Description

An additional cec adjudication re-assessment was received and it was determined that a myocardial infarction did not occur.

Manufacturer Narrative

Correction: b5, g1, h6.

• 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: tonia moskalets ; 1225 old highway 8 nw; st paul, MN 55112 ; 6512591600
• MDR Report Key: 18497499
• MDR Text Key: 332725508
• Report Number: 3004742232-2024-00047
• Device Sequence Number: 1
• Product Code: MCX
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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 Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White