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

Model Number DBEC-125

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.H6 health effect - clinical code 4581: slow/no flow.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) and viperwire advance coronary guide wire with flex tip were used to treat two diffuse, heavily calcified, 80% stenosed lesions in the proximal/mid and mid/distal left anterior descending (lad) artery via antegrade femoral approach.Two low-speed treatments in the proximal and mid lad were performed.Treatment in the mid and distal lad followed.During the first treatment in the distal lad when the control knob was fully advanced angiographic imaging revealed oad driveshaft buckling.The oad became stuck on the guide wire and were removed together.Following balloon angioplasty, perforation in the distal lad was observed.In the opinion of the physician, the oad caused the perforation.Balloon tamponade was used to resolve the perforation but there was no flow to distal apical lad.As the patient was stable, the patient was discharged to heal and asked to come back to restore flow to distal vessel.

Manufacturer Narrative

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.The oad was returned to csi with the guide wire spring tip lodged in the oad driveshaft tip bushing.The spring tip coils are elongated at the proximal solder bond, but no fractures were observed.No other driveshaft or handle assembly damage or abnormalities were identified that would have contributed to the reported complaint.The crown diameter met drawing specification when measured.When tested, the oad functioned as designed.Scanning electron microscopic (sem) analysis of the guide wire spring tip filars after removal from the tip bushing showed evidence of axial damage.The absence of rotational damage was noted.This is consistent with the spring tip being pulled into the driveshaft while the crown was not spinning.The root cause of the stuck device is considered to be use not consistent with the instructions for use (ifu).The ifu cautions to use fluoroscopy to monitor and maintain spacing between the driveshaft and guide wire spring tip throughout the procedure and to always keep more than 5mm of spacing between the distal end of the oad driveshaft and the proximal end of the guide wire spring tip.If the distance between the driveshaft tip and the viperwire guide wire spring tip is insufficient, the driveshaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that a perforation of vessels and no flow to vessels are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18459880
• MDR Text Key: 332262851
• Report Number: 3004742232-2024-00009
• Device Sequence Number: 1
• Product Code: MCX
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 451265-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 115 KG