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

Model Number PRD-SC30-MICRO

Device Problems Entrapment of Device (1212); Unintended System Motion (1430)

Patient Problem Perforation of Vessels (2135)

Event Date 05/15/2020

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

The stealth peripheral orbital atherectomy device was selected for treatment of a proximal lesion located in the anterior tibial artery.The vessel was 70% stenosed, and 3mm in diameter.The oad was operated on low speed and jumped forward on the first treatment pass.On the third treatment pass the oad stopped spinning.All expected leds were visibly lit at this time.Repositioning of the oad was attempted, however it was stuck on the guide wire.Glideassist mode was used to remove the oad from the patient's body and the guide wire remained in place.A vessel perforation was observed after the oad was removed.Balloon angioplasty was performed at 8 atmospheres for one minute.Imaging still showed extravasation and a blood pressure cuff was placed below the knee and inflated for one hour.After several hours of monitoring the patient, imaging showed no signs of a perforation and the patient was discharged home.

Manufacturer Narrative

The reported stealth peripheral orbital atherectomy device (oad) was received at csi for analysis.Visual examination of the driveshaft revealed that it was overloaded and had a wavy deformation along the mid-section area.This damage was consistent with the spinning driveshaft coming into contact with sudden resistance and being brought into a stall condition.The driveshaft damage also prevented a guide wire from passing through.This may have been a contributing factor to the device becoming stuck on the wire, however as the device was removed from the guide wire during the procedure, this could not be confirmed through analysis.When tested for functionality, the oad spun on all speeds as expected, and there was no driveshaft jumping observed.The data log download confirmed that the oad had a stall event during the third attempt to spin on low speed, which stopped the motor.The vessel perforation could not be confirmed through analysis.At the conclusion of the device analysis, the report that the device was stuck on the wire, the driveshaft jumped and a perforation occurred could not be confirmed.The reported event that the oad stopped spinning could not be confirmed through testing, however it was confirmed via the data download.The root cause of the reported events could not be determined.The stealth peripheral orbital atherectomy device instructions for use manual states that perforation is a potential adverse event, that may occur and/or require intervention.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.Csi id: (b)(4).

• 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
• MDR Report Key: 10139376
• MDR Text Key: 194679591
• Report Number: 3004742232-2020-00154
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)220228(10)314836
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 314836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR