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

Model Number DBEC-125

Device Problem Unintended System Motion (1430)

Patient Problem Vascular Dissection (3160)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is complete.Csi id: (b)(4).

Event Description

A lesion in the tortuous mid left anterior descending (lad) artery was being treated and it was observed that a diagonal came off in the area needing treatment.The vessel was wired with a workhorse wire and used a teleport microcatheter to exchange for viperwire advance guidewire.The diamondback 360 coronary orbital atherectomy device (oad) was loaded, and glide assist was used to get to the lesion.It was suggested to the physician to peck and release until crown worked its way through to achieve 1-1 motion.The first treatment was 15 seconds with 15 seconds of rest.During the second treatment, the crown jumped distally in the vessel as the lesion was treated proximal to distal.During the third treatment, the oad stopped spinning.It was advised to stop the treatment and remove the oad.The oad appeared stuck on the guidewire and glide assist was used to remove it out of the body.The guidewire remained in vivo.Upon removal, angiographic imaging revealed a major dissection.Following safe removal, an attempt was made to cross the lesion with the wire, however difficulty was observed to cross the lesion despite the wire being across.It was attempted to use the teleport microcatheter again and after failed attempts, a balloon pump was inserted, and the patient was scheduled to have surgical bypass later on the same day.The patient was not previously scheduled for bypass and bypass was the result of the adverse event.The patient received a left internal mammary artery (lima) to the lad.The patient was discharged from the hospital in stable condition.In the physician's opinion, it was suspected that the issue occurred due to an error related to the oad and more tortuous vessels were treated by the oad previously.It was also noted by the physician that there was no damage observed to either the driveshaft or guidewire.

Manufacturer Narrative

H6 investigation conclusion code 22: functional testing of the oad showed that the oad functioned as intended.Speed testing of the device showed that the device spins at the intended speeds.There was no damage or abnormalities identified with the crown or driveshaft that would have contributed to the reported complaint.Also, the crown was measured and met drawing specifications.At the conclusion of failure analysis investigation, the device functioned as intended when tested.Scanning electron microscopy (sem) analysis of the tip bushing did not find any evidence of radiopaque particles, indicating that the device did not make contact with the guide wire spring tip.Review of the device data log identified a stall event during the procedure.It is unknown if the stall event is related to the reported complaint.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this reviewthat 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 highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul, MN 55112
• MDR Report Key: 18400449
• MDR Text Key: 331417653
• Report Number: 3004742232-2023-00305
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250531(10)490971-1
• 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: 02/09/2024

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: 7-10060-09
• Device Lot Number: 490971-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 200 KG