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

Model Number 1286

Device Problems Crack (1135); Difficult to Remove (1528)

Patient Problem Injury (2348)

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

It was reported that difficulty was encountered upon removal of the catheter.Catheter was pulled out with force.Physician believed that the catheter was held in place due to a diffuse esophageal spasm.There was bleeding in the nose, which was taken care of by the ent department.

• 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: 5412039
• MDR Text Key: 37516928
• Report Number: 9710107-2016-00012
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2016
• 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