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

Model Number DBP-125MICRO145

Device Problems Entrapment of Device (1212); Unexpected Shutdown (4019)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/11/2019

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.(b)(4).

Event Description

During a procedure, the diamondback peripheral orbital atherectomy device (oad) became stuck in the distal anterior tibial (at) artery.Balloon angioplasty was performed to attempt to loosen the device, but the attempts were unsuccessful.The device was unable to be removed and the patient was taken to surgery for removal.During surgery, the oad was able to be removed.The patient status was fine a couple of days following the procedure.

Manufacturer Narrative

Csi id# (b)(4).

Event Description

The target lesion was diffusely calcified and located throughout the entire at.The vessel was mildly-to-moderately tortuous and 3.5mm in diameter.Two to three treatment passes were performed, and the oad sounded like it was losing speed and eventually stopped spinning.The oad was restarted and became stuck in the mid-to-distal at on the next treatment pass.

• 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
• MDR Report Key: 8767848
• MDR Text Key: 150278127
• Report Number: 3004742232-2019-00173
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-125MICRO145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention