MAUDE Adverse Event Report: SANDHILL SCIENTIFIC, INC. INSIGHT ULTIMA; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number UNI-ESO-WG1A1

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  malfunction  

Event Description

Esophageal manometry catheter, prior to placement inpatient, was quality control checked and verified as working appropriately.Esophageal manometry was successfully placed and visualized with endoscope, then secured to patient cheek with tape.Connected patient esophageal manometry catheter to sandhill manometry computer/software only to note that red color, denoting high pressures across catheter, were present, which is not typical presentation for esophageal manometry tracing while in patient.Dr.Immediately notified as rn had concern of catheter malfunction.Dr did view tracing and also agreed that it appeared to be catheter malfunction.Attempt to reposition esophageal manometry catheter per protocol, but manometry tracings still indicated red pressure bands across entire tracings, not making it possible to complete esophageal manometry study.Removed esophageal manometry catheter intact with no visible damage.When catheter was outside patient body, red pressure bands continued to be present despite hanging in mid-air with no pressure applied to catheter.

• Brand Name: INSIGHT ULTIMA
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): SANDHILL SCIENTIFIC, INC.; 9150 commerce center cir no 500; highlands ranch CO 80129
• MDR Report Key: 5496647
• MDR Text Key: 40212687
• Report Number: 5496647
• Device Sequence Number: 1
• Product Code: FFX
• 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: Other
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNI-ESO-WG1A1
• Other Device ID Number: K123245E1047D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1