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

Model Number C-2DB-CL125-135

Device Problems Entrapment of Device (1212); Unintended System Motion (1430); Material Separation (1562)

Patient Problems Angina (1710); Hematoma (1884); Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2024

Event Type  Injury  

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used in an attempt to treat a right coronary artery (rca).During the procedure, the oad glideassist was used to advance to the segment 3 next to dense stenosis.The patient experienced angina and during angiography, timi 0-1 flow was found distal to the stenosis in segment 2.Glideassist was used to back the oad into segment 2.The oad was used to perform a few low-speed treatments proximal to the stenosis in retrograde and antegrade directions.Distal flow improved and the patient became pain free.Glideassist was used to advance the oad to the distal stenosis.During this, the patient had renewed angina and timi 0-1 flow was observed distally in the vessel.Several low-speed treatments were performed in segment 3 in the antegrade direction.An unusual noise was observed with the crown.After a few treatments, the crown approached the most distal portion of the stenosis.Suddenly, the crown jumped forward and a vibration was felt with the oad.The oad stalled.The patient stated they felt better, and angiographic imaging assess that timi flow was present.The oad was attempted to be turned back on with glideassist activated, however, the oad continued to shut down.The physician felt vibration with the oad once again.Angiographic imaging still showed timi flow in the periphery of the vessel but a new discontinuity of the oad was observed at the transition from segment 2 to 3, approximately 3-4 centimeters proximal to the crown.The physician attempted to remove the oad, however, it appeared stuck.Several attempts to bypass the transition with non-csi/non-abbott devices were made, but unsuccessful.Various balloons were able to be advanced.A balloon was gently expanded, and flow improved slightly.At this time, the patient's symptoms improved, electrocardiogram (ekg) and blood pressure readings normalized.Several additional attempts were made to mobilize the oad to withdraw, but they were still unable to remove the oad.In the physician's opinion, the kinking/twisting and partial detachment of the oad with entanglement between segments 2 and 3 of the rca is what led to the oad becoming stuck.The oad was still on the viperwire at this time.The introducer, including the guide catheter and oad were left in the right groin of the patient, wrapped in sterile plastic and secured.Medication was administered and the patient was in stable condition.The patient was transferred to a hospital, where thoracic surgery was to be performed.When the patient arrived for thoracic surgery, the patient was hemodynamically unstable, mainly due to a large left groin hematoma caused by bleeding from the puncture site.The 6f introducer had dislodged from the vessel during transport to the hospital.The bleeding was resolved by prompt angiography and apposition of 2 covered stents in the common femoral artery.The right groin was maintained a 6f introducer with a 6f coronary guiding catheter and a plugged tuohy y-connector.Exiting the valve was what was left from the outer catheter of the oad, cut from the control unit.No oad driveshaft or viperwire were observed until removal of the outer sheath, when 10-15 centimeters of the oad driveshaft and 1cm of the viperwire were extending from the shaft.Multiple balloons were attempted to be used to remove the oad driveshaft and viperwire, but were unsuccessful.A guiding catheter was used in an attempt to remove the oad driveshaft, however, this was unsuccessful as well.During high-resolution cine imaging, it was observed the driveshaft proximal to the crown had been deformed but not completely detached and fibers were impeding over the wire advancement of the 5f catheter despite being dilated with larger balloons prior.A final attempt to remove the oad was made with a microcatheter, and this failed as well.In the surgeon's opinion, the twisted portion of the device was anchored into the vessel and there was large hematoma in the vessel wall.The component was left in the patient and the patient was to continue on anticoagulation medication.The patient was in stable condition.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.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: 19119032
• MDR Text Key: 340340574
• Report Number: 3004742232-2024-00170
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)250930(10)508922-1
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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: C-2DB-CL125-135
• Device Catalogue Number: 7-10060-03
• Device Lot Number: 508922-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 87 KG