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 Vascular System (Circulation), Impaired (2572)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

The oad was received for analysis.No visible damage was observed.A guide wire was passed through the oad with no resistance.When tested, the oad functioned as intended.At the conclusion of the device analysis, the reported event of slow flow was unable to 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.Csi id# (b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a lesion from the superficial femoral artery to the popliteal artery.The lesion was initially wired with a non-csi guide wire and an exchange was performed for a viperwire guide wire.The lesion was divided into five (5) segments, and each segment was treated with one treatment on low, two treatments on medium, and two treatments on high speed.The treatments were all 30 seconds, and vasodilators were administered twice during treatment.After treatment, slow flow was observed.Balloon angioplasty was performed.Lumen gain was observed, however, the flow was still slow.Stents were deployed in the sfa.The final angiography showed slower flow than baseline angioplasty.The possibility of dissection was ruled out.The physician does not plan to administer additional treatment for the slow flow.

• 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: 10434600
• MDR Text Key: 203986488
• Report Number: 3004742232-2020-00254
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491080
• UDI-Public: (01)10850000491080(17)220228(10)259471
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBE-200
• Device Lot Number: 259471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 67