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

Model Number DBEC-125

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The oad was received at csi for analysis engaged on the guide wire.Visual examination revealed a driveshaft fracture at the nose cone.Scanning electron microscopy analysis revealed the driveshaft fractured due to fatigue.The saline sheath near the nose cone was also damaged.The nose cone glue plug exhibited insufficient adhesive around the glue plug bond, which created a fluid leak path.When tested, fluid was observed leaking from the nose cone plug and saline sheath damage; however, no fluid exited the distal end of the sheath.The guide wire was removed with resistance due to the observed driveshaft damage.The driveshaft damage was removed, and the wire was reinserted into the driveshaft and handle assembly without resistance.At the conclusion of the device analysis, the reported strain relief damage and lack of saline flow through the device was confirmed.The insufficient adhesive seal around the glue plug leak was due to a manufacturing issue.This caused fluid to leak out of a different site, instead of through the tip of the device.The strain relief detachment was confirmed; it is hypothesized that this occurred due to handling, but the exact cause was unknown.The driveshaft fracture observed during analysis may have occurred due to lack of fluid flow leading to high interference and resistance between the driveshaft and sheath.However, this could not be confirmed.The exact root cause of the damage remains undetermined.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 strain relief of the diamondback coronary orbital atherectomy device (oad) detached, and fluid leaked from the nose cone.Saline flow to the nose of the oad was hindered, and the guide wire became stuck to the device.Both were removed and replaced to complete the procedure.A delay of 30 minutes or more occurred.

• 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
• 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: 12128921
• MDR Text Key: 260764151
• Report Number: 3004742232-2021-00247
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230228(10)366718-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 07/07/2021

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: 02/28/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 366718-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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
• Patient Age: 72 YR
• Patient Weight: 91