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

Model Number DBEC-125

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received for analysis.An in-house guide wire was passed through the oad with no issue.The oad was connected to an inhouse saline pump, and the leds illuminated and defaulted to low speed as expected.The speed switch led buttons allowed toggling from low to high and high to low, however when tested the device would not spin on low or high speed.The oad did spin properly for glide assist, however the device would not stop spinning in glide assist mode when the brake lever was either activated or deactivated.Evaluation revealed that there was a lack of electrical continuity between the brake switch membrane cable and the terminal connector.Potting material had wicked between the terminal connector pins and the brake switch ribbon which prevented electrical continuity through the system.When the potting material was removed from the brake switch connector and the oad was retested, the oad spun at both speeds as intended, and glide assist functioned and stopped as intended.At the conclusion of device analysis, the event of the oad not spinning was 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.(b)(4).

Event Description

During a procedure, the diamondback coronary orbital atherectomy device (oad) was positioned in the right coronary artery (rca) with glide assist.After positioning the oad, the oad would not turn on at low speed.The oad was repositioned using glide assist and the saline pump was cycled off and on again.The oad turned on at low speed and was used for one 10 second treatment pass in the rca.After a rest period of 20 seconds, the oad would not turn on.The oad was removed from the patient and would not turn on when testing outside of the patient.A second oad was used to complete the procedure with no patient complications.Device analysis identified that the device would not stop spinning in glide assist mode when the brake lever was activated or deactivated.Based on this information, this was determined to meet the definition of a reportable event.

Manufacturer Narrative

Device analysis identified that the device would not stop spinning in glideassist mode when the brake lever was activated or deactivated.This analysis finding was reviewed by csi and it was determined it does not meet the definition of a reportable event since the glideassist function does not induce appreciable orbit of the crown.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8492213
• MDR Text Key: 147606785
• Report Number: 3004742232-2019-00097
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)201231(10)251139
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 251139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 70