MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES MANOSCAN ESO Z CATHETER; SYSTEM, GASTROINTESTINAL MOTILITY

Model Number 3890

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used manoscan eso z catheter was received for evaluation.The returned sample met specification as received by medtronic.The reported condition was not confirmed.A visual inspection revealed a cut along the silicon tubing.All sensors and impedance rings are functional.Additional functional testing was performed and the device was found to function normally and within specifications.

Event Description

According to the customer, an hrm catheter was getting stuck during extrubation.The patient presented discomforted during the extubation process.There was no injury to the patient.

• Brand Name: MANOSCAN ESO Z CATHETER
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5612685
• MDR Text Key: 43842702
• Report Number: 9710107-2016-00195
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1