MAUDE Adverse Event Report: MCPHERSON ENTERPRISES, INC. SMITHWICK CAROTID SHUNT; CLAMP, VASCULAR

Model Number DBD 1009PT

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Blood Loss (2597)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Shunt had a leak in the tubing near the shunt.Dr (b)(6) placed drape tape over the hole.The pt experienced increased blood loss but no permanent injury.

• Brand Name: SMITHWICK CAROTID SHUNT
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MCPHERSON ENTERPRISES, INC.; pinellas park FL 33781
• MDR Report Key: 8432554
• MDR Text Key: 139299165
• Report Number: MW5084990
• Device Sequence Number: 0
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: DBD 1009PT
• Device Lot Number: CS013118-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Required Intervention
• Patient Age: 65 YR