MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE); PERIPHERAL ATHERECTOMY SYSTEM

Device Problem Difficult to Insert (1316)

Patient Problem Perforation of Vessels (2135)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.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.Csi id: (b)(4).

Event Description

A viperwire advance guide wire was used with a non-csi catheter.The viperwire could not pass through the orbital atherectomy device.The guide wire was removed and an angiogram was performed through the catheter which revealed a perforation.Balloon angioplasty was performed to resolve the perforation.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE)
• Type of Device: PERIPHERAL ATHERECTOMY SYSTEM
• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15250948
• MDR Text Key: 298149474
• Report Number: 3004742232-2022-00191
• Device Sequence Number: 1
• Product Code: MCW
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic