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

Model Number /DBP-150SOLID145

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Tachycardia (2095)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event was related to use not consistent with the instructions for use.The peripheral orbital atherectomy systems (oas) ifu warns the oas cannot be used in coronary arteries.Furthermore, treatment of a lesion within a bypass graft or stent is listed as a contraindication.Csi id: (b)(4).

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat an 70% stenosed, severely calcified, proximal left anterior descending artery (lad).Following a twenty-five second treatment, the oad bogged down and stopped spinning.It was advised that the physician discontinue treatment as they were using the oad off-label.The patient experienced chest pain.During removal of the oad, the device became stuck in the vessel.The driveshaft and coronary viperwire guide wire were cut at the oad handle.The physician attempted to use excessive force to remove the cut driveshaft and guide wire, however, was unsuccessful.A snare was used to remove the system.The crown wrapped around an existing stent and the stent came out with the oad.Following, the patient coded on the table.Chest compressions were administered.The patient was revived and a temporary ventricular support device was placed.The patient remained stable.A new guide wire was advanced into the vessel.Following, the patient went into ventricular tachycardia which was resolved with defibrillation.Three stents were placed in the lad and circumflex artery.The patient was stable.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16600903
• MDR Text Key: 311922762
• Report Number: 3004742232-2023-00075
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: /DBP-150SOLID145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White