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

Model Number RFG-3890

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Customer reported difficult catheter removal.Physician stated that lubricant was used to try to assist with removal.Patient sent to ent where the catheter was removed without significant difficulty.Catheter removed by simply pulling a little harder on the catheter itself.No other intervention was required, no bleeding was noted, and patient had no significant symptoms at discharge.Since image modalities were not used, ent physician could not comment on any underlying anatomical variations.

• Brand Name: MANOSCAN ESO 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: 5445689
• MDR Text Key: 38511318
• Report Number: 9710107-2016-00022
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFG-3890
• Device Catalogue Number: RFG-3890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other