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

Model Number DBEC-125

Device Problems Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

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 diamondback coronary orbital atherectomy device (oad) became stuck on the guide wire during treatment in a highly calcified lesion in the circumflex artery, which was 90% stenosed.The distal tip of the oad appeared to unravel but did not fragment.The procedure was continued with a second oad with a delay of greater than 30 minutes.The procedure concluded without further consequence to the patient.

Manufacturer Narrative

The oad was received at csi for analysis along with the guide wire utilized during the procedure.Adhered biological material and suspected corrosion was observed on the driveshaft, crown, and driveshaft tip bushing area.The morphology and exact root cause of the accumulating biological material is unknown.Examination in the areas of the accumulation did not reveal any damage that would have contributed to the tissue accumulation.Upon examination of the driveshaft, the tip of the driveshaft exhibited damage.This type of damage is consistent with spinning the device into an extremely tight calcified lesion with excessive force.The oad was found to operate at all three speeds with no abnormalities or unusual noises observed.At the conclusion of the device analysis investigation, the reported oad damage was confirmed.However, the reported stuck-on-wire event could not be conclusively confirmed as the device was received with the guide wire not engaged in the device.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution.Additional information unrelated to the event: examination of the guide wire revealed the spring tip to be detached and missing from the wire with some adhesive residue located on the wire.The adhesive residue originated from normal manufacturing processes and was not abnormal.Follow-up communication with the site indicated the operating room technician forcefully attempted to remove the stuck guide wire from the oad after the devices were removed from the patient, and the tip of the guide wire became detached in the attempt.The material inspection report for this guide wire 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).

Manufacturer Narrative

The reported oad was received for analysis along with the guide wire utilized during the procedure.Adhered biological material and suspected corrosion was observed on the driveshaft, crown, and driveshaft tip bushing area.Upon examination of the driveshaft, the tip bushing exhibited surface damage and deformed, overloaded filars.This type of damage is consistent with spinning the device into an extremely tight calcified lesion with excessive force.The oad was found to operate at all three speeds with no abnormalities or unusual noises observed.At the conclusion of the device analysis investigation, the reported event of the tip bushing of the oad being damaged was confirmed through analysis, however the reported event of the oad becoming stuck on the guide wire could not be conclusively confirmed through 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.The material inspection report for this guide wire 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.Additional information unrelated to the event: examination of the guide wire revealed the spring tip to be detached and missing from the wire with some adhesive residue located on the wire.Follow-up with the site indicated the operating room technician forcefully attempted to remove the stuck guide wire from the oad after the devices were removed from the patient, and the tip of the guide wire became detached in the attempt.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: 8184320
• MDR Text Key: 131709328
• Report Number: 3004742232-2018-00370
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200630(10)231669
• 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,Followup
• Report Date: 01/17/2019

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: 06/30/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 231669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/11/2019; 01/11/2019
• Supplement Dates FDA Received: 01/16/2019; 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 80