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 Problem Perforation of Vessels (2135)

Event Date 03/27/2024

Event Type  Injury  

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used to treat a 2.5mm, 90% stenosed, heavily calcified with mild tortuosity left anterior descending artery (lad).The oad was spun for one treatment on low speed and a perforation was observed in the mid lad.The patient declined, cardiopulmonary resuscitation (cpr) was performed for twenty to thirty minutes while simultaneously performing pericardiocentesis and extracorporeal membrane oxygenation (ecmo).One liter of blood was drained from the heart.Three non-csi/abbott balloons and three non-csi/abbott stents were used and placed to successfully treat the perforation.Flow was restored and the patient was stable and placed on a ventilator and transferred to the intensive care unit (icu).The following day the patient's dependance on the ventilator was reduced.It was the physician's opinion the oad caused the perforation.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.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).

• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19095968
• MDR Text Key: 340018947
• Report Number: 3004742232-2024-00157
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250831(10)504173-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 504173-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• 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: Female
• Patient Weight: 62 KG