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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

The reported oad was received at csi for analysis, engaged on the guide wire. Visual examination revealed adhered biological material on the proximal and distal edge of the driveshaft crown. A guide wire was inserted into the oad and met some resistance at the area of adhered material, and was able to pass through the remaining driveshaft without issue. When tested, the oad was powered on and off and spun on all speeds. Review of the device data log revealed numerous stall conditions. At the conclusion of the device analysis investigation, the reported dissection and stuck in vessel events could not be confirmed through analysis. The accumulated tissue may have contributed to the dissection and stuck in vessel events, however this could not be confirmed. There was no damage observed that would have contributed to the material accumulation and the root cause of the accumulated material was unknown. 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 diamondback coronary orbital atherectomy device (oad) was operated for several treatment passes in the posterior tibial (pt) artery, and during the removal process the oad could not be removed from the patient's body. Glideassist was activated, and the oad momentarily spun before it stopped spinning. Nitroglycerin was administered, however the oad remained stuck in the vessel. The oad and wire were removed and wire access was lost. A type f dissection was observed in the lateral plantar artery and balloon angioplasty was used to resolve the dissection.

• 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: 11966755
• MDR Text Key: 255353916
• Report Number: 3004742232-2021-00207
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 350406-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/09/2021 Patient Sequence Number: 1