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

Model Number VPR-GW-EL14

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2021

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. (b)(4).

Event Description

Orbital atherectomy treatment was successfully performed via left radial access to the left popliteal (pa) and common femoral arteries without issue, and the orbital atherectomy device was removed from the patient's body. A balloon was inserted over the viperwire guide wire to treat the pa and balloon angioplasty was successfully performed. During the removal process the balloon became stuck, and the guide wire was pulled, however a kink was observed in the guide wire which prevented the balloon from being removed. The sheath, balloon and wire were pulled back into the mid aorta and access to the right groin was obtained in order to snare the wire from below, however this attempt was unsuccessful. The balloon, wire and sheath were then removed from the radial access site. Imaging was performed and confirmed a type f dissection in the axillary artery and a vessel spasm in the radial artery. Vascular surgery was consulted, and it was determined that no further treatment was required and the patient would be monitored, however the following day a coronary bypass surgery was performed. The patient was discharged in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 11890521
• MDR Text Key: 262657517
• Report Number: 3004742232-2021-00189
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: VPR-GW-EL14
• Device Catalogue Number: 7-10035-01
• Device Lot Number: 362913-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/26/2021 Patient Sequence Number: 1