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

Model Number PRD-SC30-125

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 02/16/2022

Event Type  Injury  

Event 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.

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
• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13801804
• MDR Text Key: 287536250
• Report Number: 3004742232-2022-00063
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)221130(10)356286-1
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic