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

Model Number DBEC-125

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

Patient Problems Cardiac Arrest (1762); Pain (1994); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271); Pulmonary Hypertension (4460)

Event Date 10/21/2022

Event Type  Death  

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 patient experienced a myocardial infarction.Stent placement was performed in the circumflex artery.The following day, access was obtained via right radial artery and wire exchange was performed.The diamondback 360 coronary orbital atherectomy device (oad) was advanced with glide assist activated in the heavily calcified lesion in the proximal to mid right coronary artery (rca).Treatment was performed on low speed.On the third treatment, the patient experienced a sudden pain.Angiographic imaging revealed a perforation.Cardiac tamponade was performed.The patient went into cardiac arrest.The patient deteriorated rapidly with agonal breathing and profound hypertension.Cardiopulmonary resuscitation (cpr) was performed for 22 minutes; however, the patient coded.Pericardiocentesis was performed, and medication, including epinephrine, levophed, and bicarbonate were administered.The patient was intubated.The patient did not stabilize and expired.

• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 15814621
• MDR Text Key: 303815591
• Report Number: 3004742232-2022-00282
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240731(10)441982-1
• 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

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: 07/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 441982-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White