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

Model Number	PRD-SC30-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) was used via femoral access and contralateral approach.The distal target vessel was approximately 2-2.5mm in diameter, and the lesion was a chronic total occlusion.The lesion was heavily calcified with no tortuosity.The first low-speed treatment was successful.A medium-speed treatment was initiated, and an unexpected audible noise was observed.The oad could not be removed past the proximal portion of the anterior tibial artery and was apparently trapped in a dissection plane.After multiple attempts at pulling the oad, the attempt was abandoned.The physician attempted to obtain pedal access to try to snare or break the oad free.Pedal access was not an option due to vessel characteristics.As a last effort, the driveshaft and saline sheath were cut so that the physician could use a 100cm guide catheter over the saline sheath to try to capture the crown.The attempt was not successful.The physician then unsuccessfully attempted to wire the at and pass a small balloon to try and free the crown.The decision was made to make arrangements with a surgeon and a transport team in order to move the patient safely to the or with the 6fr sheath, saline sheath, and driveshaft still in the patient.The patient was transported for surgical removal and was recovering as of on (b)(6) 2022.
Additional Manufacturer Narrative
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.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.It was not clear whether or not the device had caused the initial dissection.Therefore, csi could not be ruled out as contributory to that specific adverse event.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13801804
• Report Number: 3004742232-2022-00063
• Device Sequence Number: 4006002
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)221130(10)356286-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 356286-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic