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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

The target treatment area was a (b)(4) stenosed, moderately calcified and moderately tortuous left anterior descending artery (lad).The diamondback 360 coronary orbital atherectomy device (oad) was spun three times on low speed for treatment.The oad was advanced again while on glideassist and the viperwire advance guide wire became unstable and the oad contacted the viperwire spring tip, resulting in loss control of the viperwire.The oad and viperwire were removed together.Ex vivo, the viperwire was observed fractured.There were no components left in vivo.Angioplasty was performed to complete the procedure.The patient was stable and did not experience impact from the reported issue.

Manufacturer Narrative

The guide wire was returned for analysis.The guide wire was fractured at the spring tip solder bond.Scanning electron microscopy (sem) was performed on the guide wire core and spring tip sections, sem identified evidence of rotational damage on the spring coil and ductile torsion on the core wire fracture face.This evidence is consistence with the spinning driveshaft contacting the spring tip leading to the fracture.The root cause of the failure is considered use not consistent with the instruction of use (ifu).The ifu warns to use fluoroscopy to monitor movement of the radiopaque diamondback 360 coronary orbital atherectomy device (oad) shaft tip in relation to the radiopaque viperwire guide wire spring tip.Always keep more than 5mm of spacing between the distal end of the oad driveshaft and the proximal end of the guide wire spring tip.[if the distance between the shaft tip and the viperwire guide wire spring tip is insufficient, the shaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.] 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 (VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19153893
• MDR Text Key: 341247985
• Report Number: 3004742232-2024-00163
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)250228(10)474395-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-02
• Device Lot Number: 474395-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG