MAUDE Adverse Event Report: COVIDIEN CARDIO THORACIC UNKNOWN; SHUNT

Model Number UNKNOWN CARDIO THORACIC

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Submit date (b)(6) 2016.An investigation is currently under way; upon completion the results will be forwarded.(b)(4).Several attempts to gather information from the customer were made.To date, no additional information has been received.If additional pertinent information becomes available, the report will be updated.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an artery shunt.The investigator reported there was a patient death while the argyle shunt was in place.This was discovered during a literature review.

Manufacturer Narrative

This complaint was discovered during a literature review.The product and lot number involved in this event is unknown.This complaint has not been confirmed.The complaint sample was not returned to the manufacturing site for review.No lot number was provided, therefore, it is not possible to perform a device history record (dhr) review.All dhr¿s are reviewed for accuracy prior to a products release.Without the sample or additional information, it is not possible to establish if there is a failure mode related to manufacturing or the device.The source literature for this event was reviewed and the death could not be attributed to the shunt or a shunt complication.A brainstorming session was performed in order to identify the possible causes for the described event.The following potential causes were identified: non device related organ failure, non-device related complications during placement procedure, incorrect catheter size selection, or contaminated catheter.Based on the information in the mentioned literature, no causes could be confirmed to be linked to manufacturing activities or to the device.The complaint sample was not returned to the manufacturing site for review.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Since the lot number was not provided and the sample was not returned, it is not possible to identify the specific products manufacturing date.Based on the reviewed literature related to this complaint, the device functioned as intended during the required time and it concludes shunting should be considered a viable treatment option.Based on the available information, the most probable causes are non-device related organ failure and non-device related complications during placement procedure.Per management discretion, an (b)(4) was initiated to perform a risk assessment linked to this complaint report.No further actions are required at this time.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling, and environmental and product biological monitoring, are in place to prevent nonconforming product from leaving the manufacturing operations.

• Brand Name: CARDIO THORACIC UNKNOWN
• Type of Device: SHUNT
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MANUFACTURING SOLUTIONS; edificio 820 calle #2; zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire st.; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5402032
• MDR Text Key: 37240653
• Report Number: 3009211636-2016-00058
• Device Sequence Number: 0
• Product Code: GYK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN CARDIO THORACIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other