MAUDE Adverse Event Report: GIVEN IMAGING VIETNAM CO LTD VERSAFLEX; ELECTRODE, PH, STOMACH

Model Number 957970

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during intubation, the customer pulled the catheter up at 8 cm from the nares and it was stuck.The nurse then removed the catheter from the patient, and the tip of the catheter was left inside the patient.The fragment tip was not expelled by the patient and it was not recovered.Patient did not experienced bleeding due to the incident.Ct scan was performed.

Manufacturer Narrative

Evaluation summary: the picture shows that the tip of catheter was bent and the billet sensor was cracked (it could be occurred after the nurse conducted to calibrate the catheter, as the catheter was confirmed to be calibrated), it shows the tip of the catheter was impacted by external force (causing the billet sensor to be cracked), and the tip of the catheter could be bent prior to intubation (to make it follow the pharynx curvature).Unfortunately, the external force and/or bending was too much, causing the catheter tip to break loose or be cracked (combining with a difficult intubation, could lead to a part of reference tip of the catheter was left inside the patient).The catheter tip could be impacted by external force which led to the crack of the catheter tip before the catheter was intubated into patient body, this is a possible isolated event that occurred in handling.All catheters were inspected 100% functional thru machine and visual appearance under microscope to identify sharp edge, the crack and abnormal issue.The visual inspection result was ¿passed¿.There is no change on material, machine/equipment, manufacturing process (method), and all operators (man power) were qualified.It shows that the catheters were shipped out of manufacturing site in good condition.There is no root cause which is related to manufacturing site to be identified.The catheter tip could be impacted by external force that occurred in handling.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAFLEX
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city
• MDR Report Key: 9216648
• MDR Text Key: 163145314
• Report Number: 3007662958-2019-00001
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 04260167483931
• UDI-Public: 04260167483931
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: 957970
• Device Catalogue Number: 957970
• Device Lot Number: F1833302UA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention