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

Model Number 21012

Device Problem Suction Problem (2170)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Medtronic received information that during use of this aortic root antegrade cannula with flow guard during an aortic valve replacement procedure, upon administering cardioplegia, when trying to vent the patients heart/empty the heart using the suction lines of the custom tubing pack, the green suction line sucked flat and the customer could not remove blood from the cannula.The clinicians then swapped the green suction line for the blue suction line (attached the blue suction line to the aortic root cannula) and this line also sucked flat and they could not remove blood from the aortic root cannula or patient's heart.The inability to vent the heart was managed by taking the vent off (detached from the ¿y¿ spike) and then the customer could see blood was pouring out and they suctioned the excess with a hand sucker.The custom tubing pack was used to complete the procedure.There were no adverse patient effects as a result of this issue.Additional information was received from the customer stating they did not replace the suckers that were attached to the pump and handed up to the table and they did not cut the valves out for replacement.The flow rate was not recorded, but it would have not exceeded 1.5l/minute at its maximum.The customer stated that it would only go up this high if there was an issue with the valve to see if it was sucking.The customer stated that they can say that it was between 0.1 l/min and 0.6 l/minute for their standard practice and with this case also.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: visual inspection showed no outward signs of any damage.During the cleaning process there was flow observed from the cannula and vent line.The reason for return was not confirmed.Conclusion: the complaint is unconfirmed for a suction issue during use.There was no observed damage to the device and performance testing indicated that the device functions as intended.It is unknown what may have caused this occurrence.The device history record was not reviewed as the returned product analysis found no evidence of manufacturing issues with the returned device and the lot number is unknown.Trends for issues with this device are monitored.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: AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH FLOWGUARD
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13952197
• MDR Text Key: 288502328
• Report Number: 2184009-2022-00055
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K810548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21012
• Device Catalogue Number: 21012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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