MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPER WIRE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  Injury  

Event Description

The viperwire guide wire was advanced into the mid-to-distal left anterior descending (lad) artery, and the distal portion of the wire was placed in the apex of the heart.Balloons and the orbital atherectomy device (oad) were unable to cross the lesion.During removal of the oad it was observed that the distal portion of the guide wire had fractured and remained in the distal lad.A non-csi guide wire was inserted to retrieve the guide wire.The wire was moved proximal but could not be retrieved.A catheter was inserted over the non-csi wire with the intention of using a micro snare to retrieve the fragment; however, the catheter became stuck and was removed with some difficulty.The non-csi wire was then observed to be stuck in the patient.Attempts to retrieve the non-csi wire were made and the patient experienced adverse events as a result.An impella device was placed, and the patient's hemodynamics eventually stabilized.The patient was sent to surgery, and both wires were removed successfully.The impella was left in overnight, and the patient was reported to be out of the intensive care unit and expected to be discharged soon.

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Manufacturer Narrative

The guide wire was received at csi for analysis.A visual examination confirmed that the guide wire was fractured, and that the distal section was not returned.Evidence of excessive wear was observed near the fracture site.Scanning electron microscopy analysis showed evidence of rotational wear on the surface of the wire near the fracture site.The fracture face was too worn down to confirm the presence of fatigue.There was no evidence of contact from the oad.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed.It was hypothesized that the fracture occurred due to the oad spinning too close to the spring tip and/or being spun on in a high stress condition, such as a tight bend.However, this could not be confirmed and the root cause of the fracture was not determined.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).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPER WIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: 13109427
• MDR Text Key: 282904077
• Report Number: 3004742232-2021-00432
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)230331(10)374564-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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: 03/31/2023
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 374564-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 66 KG