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

Model Number DBP-125MICRO145

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Vascular Dissection (3160)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

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 the reported oad was unable to be reviewed, as the lot number was not provided.The diamondback peripheral orbital atherectomy device instructions for use states that dissection is a possible adverse event which can occur with use of the diamondback peripheral orbital atherectomy device.(b)(4).

Event Description

During a procedure with a diamondback peripheral orbital atherectomy device (oad), a dissection occurred.The 100% occluded, heavily calcified, 120mm long target lesion was located in an area of the right peroneal artery that was 4mm in diameter.The lesion was crossed with aggressive non-csi guide wires, and the guide wire was exchanged for a csi viperwire guide wire.It was confirmed that the guide wire was not subintimal and there were no observed dissection flaps present.After the third treatment pass on low speed with the oad, the crown of the oad caught a dissection flap, and the oad made a high-pitched noise.The oad was turned off and removed from the patient, and wire access was lost.When the device was removed, tissue was observed on the crown of the oad.The lesion was re-crossed, and the procedure was completed, and the type a dissection was treated with balloon angioplasty.Imaging after treatment confirmed there was a good result.The patient was okay following the procedure.

• 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: 9362830
• MDR Text Key: 167787045
• Report Number: 3004742232-2019-00306
• 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: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-125MICRO145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Weight: 91