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

Model Number GWC-12325LG-FT

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was returned to csi for analysis, engaged with the distal section of the cut driveshaft.A visual examination revealed that approximately 22.9cm of the guide wire was not returned.Scanning electron microscopy analysis of the guide wire fracture face showed some evidence of ductile dimples, and a possible tension failure that occurred when the driveshaft fractured.At the conclusion of the device analysis, the report that the guide wire had fractured was confirmed, and the identified fractures were hypothesized to be due to the applied forces used in attempts to remove the oad.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.The orbital atherectomy device event that occurred during this procedure has been reported under 3004742232-2021-00430.Csi id: (b)(4).

Event Description

During attempts to remove the orbital atherectomy device, the viperwire guide wire was cut and a fragment approximately 50 to 60 centimeters in length was left in vivo.Additional attempts were made to retrieve the remaining guide wire fragment including re-wiring the vessel, inserting guide catheters over the oad driveshaft and changing the sheath size, however due to the angulation of the vessel, difficulty was encountered and the attempts were unsuccessful.The guide wire and oad were manually pulled and the oad fractured, leaving the guide wire in the oad crown, which was stuck in the circumflex artery.The guide wire extended into the aorta.Due to the patient's unstable baseline, they were turned down for surgery and another attempt to snare as much of the guide wire as possible was made.After several attempts a small piece of the guide wire broke off and was retrieved, however the rest of the guide wire remained in vivo.

Manufacturer Narrative

The reported guide wire was returned to csi for analysis, engaged with the distal section of the cut driveshaft.A visual examination revealed that approximately 22.9cm of the guide wire was not returned.Scanning electron microscopy analysis of the guide wire fracture face showed some evidence of ductile dimples, and a possible tension failure that occurred when the driveshaft fractured.At the conclusion of the device analysis, the report that the guide wire had fractured was confirmed, and the identified fractures were hypothesized to be due to the applied forces used in attempts to remove the oad.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.The orbital atherectomy device event that occurred during this procedure has been reported under 3004742232-2021-00430.Csi id: (b)(4).

Event Description

During attempts to remove the orbital atherectomy device, the viperwire guide wire was cut and a fragment approximately 50 to 60 centimeters in length was left in vivo.Additional attempts were made to retrieve the remaining guide wire fragment including re-wiring the vessel, inserting guide catheters over the oad driveshaft and changing the sheath size, however due to the angulation of the vessel, difficulty was encountered and the attempts were unsuccessful.The guide wire and oad were manually pulled and the oad fractured, leaving the guide wire in the oad crown, which was stuck in the circumflex artery.The guide wire extended into the aorta.Due to the patient's unstable baseline, they were turned down for surgery and another attempt to snare as much of the guide wire as possible was made.After several attempts a small piece of the guide wire broke off and was retrieved, however the rest of the guide wire remained in vivo.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE 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: 13111889
• MDR Text Key: 286341355
• Report Number: 3004742232-2021-00431
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)230630(10)386985-1
• 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
• Report Date: 12/29/2021

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: 06/30/2023
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 386985-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American