MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED CSI WIRE; WIRE CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325L

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

During completion of a cardiac cath, the tip of the wire broke off.There were multiple attempts to retrieve without success.Fda safety report id # (b)(4).

• Brand Name: CSI WIRE
• Type of Device: WIRE CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 13887412
• MDR Text Key: 288029979
• Report Number: MW5108486
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWC-12325L
• Device Lot Number: 6235948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White