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

Model Number DBP-125MICRO145

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received at csi for analysis. Visual examination did not reveal any damage. The device was turned on and off numerous times with no issues observed. While performing function testing, the motor cable set, start switch and potted pcb were soaked with saline solution and the power button was activated with no unintended spinning observed. The oad was turned off and rested without the oad turning back on. There were no visible leak paths, and no damage to the start switch cables or the cable retainer. Further examination revealed there was no damage to the motor, cable set, brake or speed switch ribbons and no damage observed that would have contributed to the reported event. At the conclusion of the device analysis, the reported event that the oad spun independently without being prompted could not be confirmed as the oad functioned as intended during analysis. 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).

Event Description

The peripheral diamondback orbital atherectomy device (oad) spun independently without being prompted. During testing outside of the body, the oad intermittently started and stopped spinning and the saline infusion pump was used to troubleshoot the issue. After 2 to 3 seconds the oad spun without being prompted at 60,000 rpms for approximately 2 to 3 seconds before becoming caught on sterile towels in the field. The device was replaced with a second oad to complete the procedure with no major delays. The patient was discharged without any complications.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 9197898
• MDR Text Key: 191589386
• Report Number: 3004742232-2019-00269
• 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

• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 281367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial