MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); PERIPHERAL ATHERECTOMY DEVICE (GUIDEWIRE)

Model Number VPR-GW-EL14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2022

Event Type  Injury  

Event Description

The superficial femoral artery and popliteal were primary wired with a viperwire guide wire, and placement was confirmed on imaging.The treatment area was not tortuous but was highly calcified.One section of the vessel was treated with atherectomy.Thereafter, wire placement was checked and found to be in the desired location.The atherectomy device was advanced, and wire placement was again confirmed to be correct.Treatments were performed with a radial length orbital atherectomy device on low, medium, and high speed.Each treatment time was about 20-25 seconds, and rest time was equal to treatment time.During movement of the oad, the wire migrated into a small side vessel.Atherectomy was then performed in the popliteal vessel.The oad was removed, and wire position was checked on imaging.Placement at that time was observed to be less than ideal.The wire was pulled back, and imaging indicated the wire had fractured.The tip of the wire remained in the side vessel.The remainder of the wire was removed intact.Additional imaging confirmed the wire fragment was in a small side branch and not in the peroneal artery.The opinion of the physician was that the fragment would be "fine" where it was.The physician abandoned the fragment in vivo.

Manufacturer Narrative

Device analysis conclusion: the guidewire was received at csi for analysis.Visual examination confirmed the reported fracture.The distal section of the wire was not returned for analysis, which is consistent with details reported to csi.Scanning electron microscopy analysis showed evidence of fatigue with a large ductile tear and folding back onto the core wire.This evidence, along with the fracture location, is consistent with a fracture resulting from the driveshaft spinning too close to the spring tip.It is also possible there was a bend or kink near the spring tip.The root cause of the fracture is considered to be use not consistent with the instructions for use (ifu).The ifu warns, "never advance the orbiting crown to the point of contact with the guide wire spring tip.Distal spring tip detachment and embolization may result.Make sure there is a minimum of 10 cm between the guide wire spring tip and the distal end of the shaft." (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE (GUIDEWIRE)
• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 14186847
• MDR Text Key: 289871626
• Report Number: 3004742232-2022-00102
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005459
• UDI-Public: (01)10852528005459(17)231130(10)411232-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: VPR-GW-EL14
• Device Catalogue Number: 7-10035-01
• Device Lot Number: 411232-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White