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

Model Number GWC-12325LG-FT

Device Problems Off-Label Use (1494); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2024

Event Type  Injury  

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).

Event Description

A 1.5 solid diamondback 360 orbital atherectomy device (oad) was used to treat a moderately calcified, roughly 60mm-long lesion in the left distal superficial femoral artery (sfa) via contralateral right femoral access.The vessel was 6mm in diameter.The lesion was primary wired with a non-csi guide wire which was exchanged for viperwire advance coronary guide wire with flex tip using a non-csi support catheter.Following successful atherectomy, balloon angioplasty with non-csi balloon was performed.The oad was removed.During removal of the oad, excess viperwire was observed at the back end of the oad.Thinking that the viperwire just came back, the physician rewired the sfa with a non-csi guide wire and performed balloon angioplasty on the lesion with a non-csi balloon.Angiographic imaging revealed the viperwire was fractured in half with the distal portion remaining in tibioperoneal (tp) trunk and the proximal portion in the 6 x 45 sheath.The fractured component was successfully snared.The patient was stable.

Manufacturer Narrative

Additional information: h3, h6.The guide wire was returned to abbott for analysis.Analysis of the guide wire determined that it is a coronary flex tip guide wire confirming the complaint of wrong guide wire used with a diamondback 360 peripheral orbital atherectomy device (oad).The returned guide wire is fractured 222cm from the proximal end confirming the complaint of guide wire fracture.Scanning electron microscopic analysis of the fracture faces show evidence of nitinol fatigue.This type of fracture is due to use of the wire under an extreme and abnormal stress condition.It is hypothesized that the use of this coronary guide wire with a 1.5 solid peripheral oad contributed to the elevated stress condition that led to the fracture.The cause of the wire fracture is related to use not consistent with the diamondback 360 peripheral orbital atherectomy system instructions for use (ifu) user manual (92-10017-01 rev c).The ifu warns: the device is designed to track and spin only over the csi viperwire advance® peripheral guide wire or the viperwire advance® with flextip peripheral guide wire.Do not use any other guide wire with this device.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CORONARY ORBITAL ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18735598
• MDR Text Key: 335721823
• Report Number: 3004742232-2024-00110
• Device Sequence Number: 1
• Product Code: MCX
• 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: 03/15/2024

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 Model Number: GWC-12325LG-FT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Black Or African American