MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH FLOWGUARD; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 21012

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

The product will not be returning to medtronic as it was discarded by the customer.A supplemental report will be filed upon closure of the investigation if it provides new or additional information, or if other additional information is received by medtronic.(b)(4).

Event Description

Medtronic received information indicating that during a bypass procedure, there was restricted flow through this cannula, which made it difficult to purge the cardiac cavities.The procedure was prolonged for 48 minutes so the customer could ensure air did not remain in the patient's heart.The cannula was replaced with another to complete the case.No additional adverse patient effects were reported as a result of prolonging the procedure.

Manufacturer Narrative

Medtronic received additional information clarifying the details of this event.This information has been updated in the event description.Conclusion: medtronic cannot confirm or deny the complaint of a problem with the device resulting in a collapsed venting line as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record was reviewed; no abnormalities were documented during the manufacture of this product.A review of complaints received from (b)(6) 2015 for this part number and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.(b)(4).

Event Description

Medtronic received information indicating that during a bypass procedure, when attempting to use the vent line of an aortic root cannula, the customer reported the vent line collapsed potentially due to excess negative pressure.The procedure was prolonged for 48 minutes so the customer could ensure air did not remain in the patient's heart.The cannula was replaced with another to complete the case.No additional adverse patient effects were reported as a result of prolonging the procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH FLOWGUARD
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5318817
• MDR Text Key: 34133001
• Report Number: 2184009-2015-00121
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K810548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 21012
• Device Catalogue Number: 21012
• Device Lot Number: 2015100097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention