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

Catalog Number REF 70-001-0028

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 06/09/2018

Event Type  malfunction  

Event Description

Lot # cso13118-02 balloon could not be inflated.Lot # cs0 80116-01 also difficult to inflate one of the balloons.

• Brand Name: SMITHWICK CAROTID SHUNT
• Type of Device: CLAMP VASCULAR
• Manufacturer (Section D): IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC.
• MDR Report Key: 8428351
• MDR Text Key: 139217996
• Report Number: MW5084960
• Device Sequence Number: 1
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: REF 70-001-0028
• Device Lot Number: CS080116-01
• 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 Age: 80 YR