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

Model Number RAD-SC30-175

Device Problem Device Remains Activated (1525)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received for analysis.Visual examination of the device did not reveal any damage.A guide wire was inserted through the driveshaft and handle assembly without resistance.Power was applied to the device and all led lights were visibly lit, with the oad defaulting to low speed as expected.The oad was powered on and off several times without any issues observed.A saline solution was poured over the motor assembly and cable set, and the oad continued to spin and function as intended.The start switch, and brake assembly were examined and there was no damage or abnormalities observed.At the conclusion of the device analysis investigation, the reports that the oad sounded as though it were increasing in speed and would not stop spinning were not confirmed.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 prior to distribution.Csi id: (b)(4).

Event Description

During a procedure, the stealth orbital atherectomy device (oad) was operated on medium speed for one treatment pass.The oad was switched to high speed and sounded very loud as though it were increasing in speed.An attempt was made to turn off the oad using the power button, but it was unsuccessful, and the oad continued spinning.The saline pump was powered off, in order to cease power to the oad.The oad was removed from the sheath and the pump was powered back on.This caused the oad to power back up, and the same issue recurred.The device was replaced with a second oad to complete the procedure.There were no patient 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: 9380427
• MDR Text Key: 196581270
• Report Number: 3004742232-2019-00308
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005770
• UDI-Public: (01)10852528005770(17)210331(10)265106
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10058-03
• Device Lot Number: 265106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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