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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The reported core guide wire was returned along with the spring tip fragment for analysis at csi.Visual examination revealed that the core wire had fractured at the proximal solder bond, and the shaft appeared to be bent at the fracture site.Scanning electron microscopy analysis revealed the presence of ductile dimples on the fracture faces of the core wire.No additional damage was observed with the guide wire and spring tip.At the conclusion of the device analysis, the reported event that the guide wire fractured was confirmed.Although the root cause of the guide wire fracture is unknown, it is hypothesized that the spring tip fractured due to the core shaft having been bent at the proximal solder bond and then exposed to tensile forces resulting in the fractured, ductile dimples.The instructions for use of the diamondback coronary orbital atherectomy system states: "do not operate the oad if there is a bend, kink, or tight loop in the viperwire guide wire.A bend, kink, or tight loop in the viperwire guide wire may cause damage to and malfunctioning of the device during use." 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.Csi id: (b)(4).

Event Description

The viperwire guide wire was used to primary wire a lesion located in the aortic ostium region of the right coronary artery.The spring tip fractured, and per the opinion of the physician it is believed to have become stuck in some calcium.The guide wire was removed, and the fragment was not stationary in the aorta, so it could not be snared at that time.The fragment migrated into a lumbar artery.The atherectomy procedure was completed with second guide wire without further issue, and two stents were placed as planned.After stent deployment a catheter was used to snare the fragment, which became bent during retrieval.The patient was in good condition, and the plan to discharge the patient the following day did not change.

• 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: 9527401
• MDR Text Key: 183110601
• Report Number: 3004742232-2019-00339
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)210131(10)257537
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 257537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 84 YR