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

Model Number DBEC-125

Device Problems Infusion or Flow Problem (2964); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

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 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 could not be conclusively determined.Csi id: (b)(4).

Event Description

The viperwire advance guide wire was advanced into the left anterior descending (lad) artery.The diamondback coronary orbital atherectomy device (oad) was advanced over the wire with difficulty.The oad was delivered to the lesion and six treatments were performed on low speed.Following treatments, approximately 400ml's of viperslide fluid was observed to have leaked from the back of the oad.The neptune pump shut off unprompted with no lights illuminated.According to the physician, the saline was flowing adequately.Furthermore, there was no power to the handle or pump.All connections were confirmed to be secure with the power source.The oad was removed.The patient was stable.After the procedure was completed, the oad and pump were turned back on successfully, however, shortly after powered off.

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15451366
• MDR Text Key: 306090426
• Report Number: 3004742232-2022-00219
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240430(10)428937-1
• 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
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 428937-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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