MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number PRD-SC30-MICRO

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

The oad was returned to csi for analysis.The reported driveshaft fracture at the tip bushing was confirmed.Scanning electron microscopic analysis of the filar faces identified fatigue striations, indicative of a high stress environment.The exact root cause of the fracture is undetermined.The device history record for this oad 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).

Event Description

Via tibiopedal access, a viperwire advance guide wire was advanced through a heavily occluded, calcified lesion with a.014 buddy wire.The viperwire was positioned distal to the lesion.Using a stealth 360 peripheral orbital atherectomy device (oad), multiple unsuccessful attempts were made on low speed to cross the lesion.The tip bushing did not advance past the lesion, thus the crown was unable to engage with the calcium.Fluoroscopy revealed no advancement with the oad.The oad stopped spinning as it had been over torqued.The oad was removed from the patient.Fluoroscopy was performed and revealed the tip bushing had fractured and remained in vivo.When removing the buddy wire, the tip of the buddy wire caught the tip bushing fragment.The buddy wire and tip bushing fragment were removed from the patient.The procedure was stopped as no device was able to be advanced through the lesion.Following the procedure, the patient was in stable condition.In the opinion of the physician, the tip bushing became lodged behind calcium and fractured during retraction of the device.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 15912397
• MDR Text Key: 304784942
• Report Number: 3004742232-2022-00286
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)231231(10)412715-1
• 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: 12/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 412715-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic