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

Model Number DBE-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 07/16/2020

Event Type  Injury  

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.(b)(4).

Event Description

During a peripheral procedure, a csi orbital atherectomy device was used to treat a lesion from the superficial femoral artery (sfa) through the anterior tibial (at) artery.The lesion had 60-80% stenosis, was heavily calcified, and the vessels had mild tortuosity.The at was treated with balloon angioplasty, and orbital atherectomy was then performed from the sfa to the popliteal artery with 6 treatments on low speed, 3 treatments on medium speed, and 6 treatments on high speed.Additional balloon angioplasty was performed from the popliteal artery through the at.Haziness was identified on imaging in the mid-at.It was noted that flow after orbital atherectomy had been normal.Small, hard, white matter was aspirated, and the haziness was no longer visible under fluoroscopy.The opinion of the physician was that the white matter was a result of orbital atherectomy.Additional balloon angioplasty was performed in the sfa to complete the procedure with satisfactory results.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10391958
• MDR Text Key: 202410685
• Report Number: 3004742232-2020-00238
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491080
• UDI-Public: (01)10850000491080(17)211231(10)250579
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: DBE-200
• Device Lot Number: 250579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: 59 YR