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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is complete.

Event Description

A diamondback 360 coronary precision orbital atherectomy device (oad) was used with glideassist to advance into a tortuous, heavily calcified, 85% stenosed, 3.5 mm circumflex artery (cx).The oad became stuck in the vessel and glideassist was attempted to be used to retract the oad.However, the oad repeatedly stalled.During this event, the oad lights remained illuminated.A buddy wire and guide liner were advanced next to the viperwire advance guide wire and oad.The physician used a balloon next to the oad.The oad was able to be successfully removed.The oad was then advanced to treat the left anterior descending artery (lad).A perforation was observed.In the physician's opinion, the perforation was caused by the viperwire.The distal lad was coiled to treat the perforation.The patient was in stable condition.

Manufacturer Narrative

The oad was returned without the guide wire.Review of the device data log identified stall events on glideassist mode during the procedure.The cause of the stall event was unable to be determined.The crown diameter was measured and met specification.When tested, the oad functioned as intended.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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18874274
• MDR Text Key: 337312870
• Report Number: 3004742232-2024-00124
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)251231(10)517201-1
• 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,Followup
• Report Date: 04/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 517201-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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
• Treatment: UNKNOWN CORONARY VIPERWIREUNKNOWN LOT NUMBER
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic