MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE; CATHETER, PERIPHERAL, ATHERECTOMY

Lot Number 165903

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Wire kinked inside the patient.It was retrieved successfully.

• Brand Name: VIPERWIRE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 14740 kirby dr.; houston TX 77047
• MDR Report Key: 6894110
• MDR Text Key: 87372588
• Report Number: 6894110
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/14/2017,09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 165903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES.; NO,