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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Vascular Dissection (3160); No Code Available (3191)

Event Date 04/17/2019

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

During a procedure for a patient with critical limb ischemia, the diamondback peripheral orbital atherectomy device (oad) was used to treat diffuse lesions. The patient had diffusely diseased lesions throughout the posterior tibial artery (pt), anterior tibial artery (at), and pedal loop arteries. The calcification of the lesions were moderate to severe with 75-95% stenosis depending on the area. The pt was treated with non-csi directional atherectomy, and then the entire diseased area was wired. Orbital atherectomy with the csi oad was used in the pt, and on the third treatment pass, the crown of the oad became stuck in a lesion in the plantar vessel distal to the treatment area and stopped spinning. It was noted that there was quite a bit of vessel spasms occurring during the procedure. The driveshaft and saline sheath of the oad were cut, and a non-csi catheter was used to remove the oad from the vessel. After the oad was removed, angiographic imaging was performed and a large dissection was observed affecting a long section of the lateral plantar artery. It was unknown if the dissection occurred before or after the removal of the oad. No additional intervention was performed related to the dissection. Balloon angioplasty was used to complete the procedure, and the procedure was deemed successful through ultrasound and pulsations observed in the foot indicating the patient was revascularized. The patient left the procedure in good status.

• 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 8579085
• MDR Text Key: 144006488
• Report Number: 3004742232-2019-00123
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 248308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2018
• 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: 05/03/2019 Patient Sequence Number: 1