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

Model Number PRD-SC30-125

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 06/22/2021

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. Csi id: (b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was used to treat a chronic total occlusion lesion in the superficial femoral artery via femoral access. Two treatments were administered on low speed. The oad became stuck on the guide wire during removal. The wire and oad were removed together, and wire access was lost. The procedure was delayed by 30 minutes due to difficulty rewiring the vessel. A flow-limiting dissection was observed in the area where the oad had become stuck on the guide wire. An unplanned stent was deployed over the dissection.

• Brand Name: STEALTH 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: 12207017
• Report Number: 3004742232-2021-00268
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)221231(10)358602-1
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 358602-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention