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

Model Number DBEC-125

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2024

Event Type  Injury  

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 oad was received for analysis.A fracture on the oad driveshaft was located 6.1cm from the distal end of the driveshaft.Scanning electron microscopy (sem) was performed on the fractured driveshaft sections.Sem analysis of the fractured filars show evidence of ductile torsion.Ductile torsion is an indication that a high stress condition occurred that was not spinning in nature.The fracture may be a result of pulling from a stuck condition or torqued to failure.Although the root cause of the fracture could not be conclusively determined.Review of the diagnostic analysis showed a stall event and bog (drop in speed) events occurred during the procedure.It is unknown if these events were related to the reported issue.The root cause of the stall/bogs are unknown.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).

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was advanced on glideassist to treat a 90% stenosed, moderately calcified with mild tortuosity proximal left anterior descending artery (lad).The oad was spun two times on low speed without issue.During the third attempt to spin the oad for treatment, the oad became stuck at the distal of the lad.The physician's opinion, the oad became stuck due to the narrowness of the patient's anatomy.Glideassist was activated to free the oad resulting in both a oad driveshaft and viperwire fracture.A non-csi/abbott guide wire and non-csi/abbott balloon were advanced, there was no difficulty experienced, and the balloon was dilated to perform an anchor technique to successfully retrieve the fractured components and the oad and viperwire were removed.The lesion was checked with intravascular ultrasound (ivus) and a perforation was observed and also a lesion at the distal, but ivus or a balloon could not pass through the lesion.Therefore, a non-csi atherectomy device was used followed by angioplasty and stent placement.Cineangiography was checked and a perforation was observed.Angioplasty and stent were performed to treat the perforation.The patient was stable but hospitalized.It was the physician's opinion, the perforation occurred during use of the oad, but is unsure if the oad driveshaft or the viperwire likely caused the perforation.

• 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: 19213107
• MDR Text Key: 341388033
• Report Number: 3004742232-2024-00174
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491530
• UDI-Public: (01)10850000491530(17)240731(10)443996-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/30/2024

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: 7-10060-05
• Device Lot Number: 443996-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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: 74 YR
• Patient Sex: Female