MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC VIPERWIRE ADVANCE WITH FLEX TIP GUIDEWIRE; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LG-FT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 03/19/2021

Event Type  Injury  

Event Description

Pt went to cath lab for pci procedure with rotational atherectomy of circumflex and lad lesions.During procedure had acute coronary perforation with wire fracture - emergently placed covered stent but continued to have tamponade, pericardiocentesis done and then taken to the or for emergent sternotomy, repair coronary artery, cabg.Aortic ultrasound was utilized to try to identify the wire fragment however had significant calcium in the coronary circulation that made identification difficult.Team discussed and felt attempts at dissection in order to identify wire location would be harmful, so decision made to abandon surgical attempts to find wire.Pt admitted to the sicu post-op.Fda safety report id # (b)(4).

• Brand Name: VIPERWIRE ADVANCE WITH FLEX TIP GUIDEWIRE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC; st. paul MN 55112
• MDR Report Key: 11602295
• MDR Text Key: 243560887
• Report Number: MW5100473
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/29/2021

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: 11/30/2022
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 352681-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR