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

Model Number PRD-SC30-125

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Melted (1385); Material Separation (1562); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

The reported oad and associated guide wire used during the procedure were returned, engaged.The oad saline sheath was observed to be cut, and adhered, dried biological fluid was observed in the area.The morphology and exact root cause of the accumulated material was unknown.A hole was observed to be melted in the saline sheath.It was possible the fluid leaked from the noted melted hole in the sheath material, however, this could not be confirmed due to the cut saline sheath.Driveshaft filars were observed to be deformed and fractured.The filar fractures occurred within the saline sheath, and there were driveshaft filar indentations within the sheath wall.There did not appear to be any missing fragments, however this could not be confirmed through analysis.Scanning electron microscopy of the fractured filar faces revealed fatigue striations, and areas of the outer diameter of the driveshaft had grind marks.The melted hole in the saline sheath and driveshaft damage may have been the result of localized, elevated stress levels applied to the saline sheath and driveshaft while spinning.The sheath and shaft damage is consistent with compressing the sheath onto the driveshaft with force using an adjustable touhy valve while the driveshaft was spinning.This can cause enough force to result in saline sheath melting and separation and driveshaft filar fractures.The exact root cause of the sheath and shaft damage could not be confirmed.The oad was tested, and the oad spun on all speeds with no abnormalities or unusual sounds observed.The guide wire had a deformed spring tip with no fractures observed.There was some adhered biological material observed on the spring tip, however, no damaged was identified that may have contributed to the accumulated material.The morphology and exact root cause of the accumulated material on the spring tip was unknown.At the conclusion of the device analysis, the reported events of an unusual noise, the oad becoming stuck on the guidewire, and a leak could not be conclusively confirmed.It is possible that the reported complaint of stuck on wire occurred as a result of the damage to the saline sheath and driveshaft, however this could not be confirmed.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.The material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a procedure, the stealth peripheral orbital atherectomy device (oad) made an unusual noise and became stuck on the guide wire.The physician initially cut the sheath and a bit of the driveshaft intending to advance the sheath over the crown to attempt to loosen the oad from the guide wire.However, the physician decided to remove the oad and guide wire from the patient together.A slow leak was observed on the driveshaft sheath near the distal end of the device.The vessel was rewired, and a second oad was used to complete the procedure with no patient complications.The oad was received by analysis and was found to have fractured driveshaft filars located within the saline sheath.The facility was unaware of the fractures within the saline sheath.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 9010535
• MDR Text Key: 195568292
• Report Number: 3004742232-2019-00238
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)220630(10)275625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2019

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 Expiration Date: 06/30/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 275625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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