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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/02/2022

Event Type  Injury  

Event Description

A diamondback coronary orbital atherectomy device (oad) was used via 6-7f radial access for treatment of the left anterior descending artery (lad).Six to seven treatments were performed proximal to distal.The oad was then removed for angioplasty of a ring of calcium in the proximal to mid lad.The oad was reintroduced, and treatment was performed for a focal calcified lesion with distal to proximal technique.The oad was removed for angioplasty in the focal segment.The oad was reintroduced.Treatment was performed on another focal calcified segment; three to four treatments were performed.During atherectomy of this segment, there was evidence of no flow in the lad.The patient experienced tachycardia, and the patient's pressures dropped dramatically.The patient reported feeling unwell.Adrenaline was administered and export catheters were used.Angioplasty was applied to the length of the lad, but no flow persisted.A balloon pump was delivered, and the patient stabilized.The patient was discharged (b)(6) 2022.

Manufacturer Narrative

(b)(4).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.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.In the opinion of the physician, the specific cause of the adverse event was distal emboli.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13666467
• MDR Text Key: 286565456
• Report Number: 3004742232-2022-00049
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)231231(10)413870-1
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/04/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: DBEC-125
• Device Lot Number: 413870-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male