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

Model Number DBP-125MICRO145

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

Patient Problem Perforation of Vessels (2135)

Event Date 02/26/2020

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.Imaging was utilized during the procedure, but the image was not clear enough to determine whether the csi device may have caused or contributed to the perforation, which occurred after balloon angioplasty.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.(b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a chronic total occlusion lesion in the right peroneal artery, which was about 2mm in diameter and 90% stenotic.The oad became stuck in the vessel during use due to patient movement.The patient was restless during the procedure, and the oad became stuck when the patient moved the lower limb at the same time as the lesion was being aggressively treated with atherectomy.The oad was removed after some troubleshooting which did not include additional intervention.Imaging was performed, and the image did not clearly show the area of interest.The oad was fully removed at that time.Angioplasty was then performed, and imaging was repeated.A perforation was identified in the peroneal artery.The perforation was not treated; the physician determined it would be best to avoid re-wiring the vessel and ballooning due to pre-existing outflow considerations.The patient was stable following the procedure.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 9837291
• MDR Text Key: 192635602
• Report Number: 3004742232-2020-00081
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210930(10)287864
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 287864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other