MAUDE Adverse Event Report: PERFUSION SYSTEMS PEDIATRIC ONE PIECE ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 77012

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Literature citation: datt v, kashev s, wadhwa r, malik s, naqvi e, aggarwal s.Recurrent cardiac arrests due to severe aortic flow obstruction by aortic cannula: a fatal complication.Int surg j 2022;9:1371-4.Doi: 10.18203/2349-29 (date of event): the e-published date of 27 june 2022 has been used as the event date.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.

Event Description

Medtronic received information via literature regarding a case report of a cardiac arrest due to severe aortic flow obstruction.Aortic cannulation was done using a medtronic 12 fr straight styletted cannula, venous drainage was achieved using single stage 14 fr angled dlp cannula for superior vena cava (svc) and 16 fr angled dlp cannula for inferior vena cava (ivc).During the procedure, the customer attempted to wean the patient from cardiopulmonary bypass (cpb).However, on visual assessment, the left ventricle (lv) contractility deteriorated and progressed to distension and cardiac arrest and necessitated to reinstitute cpb.The patient had three similar repeated episodes of cardiac arrest on each successful weaning from cpb and lv contractility and hemodynamics could not be maintained even with the use of very high doses of inotropes.It was also reported that the customer noted an unusual blood pressure (bp) difference at proximal to the aortic cannulation measured by direct needle insertion (90/40 mmhg) and femoral artery (fa) (30/17 mmhg).One more an attempt was made to wean off cpb under the transesophageal echocardiogram (tee) guidance.However, still there was a big difference between fa pressure and aortic pressure proximal to cannulation.Once again, the lv got distended and became almost akinetic.Consequently, the patient also developed severe mitral regurgitation (mr) with 2-3 mr jets and hemodynamic deterioration.Finally in a desperate scenario, it was decided to remove the aortic cannula even in severe hemodynamic instability (bp 31/17 mmhg), realizing that the aortic cannula might be the culprit for the deterioration of the lv function by obstructing the aortic blood flow.Following aortic decannulation, the lv contractility and hemodynamic improved gradually, (bp 90/42 mmhg) and maintained even with minimum infusion of dobutamine, milrinone.It was reported that the similar sudden fall in blood pressure was also noted following aortic cannulation, however, that was managed as usual by volume administration through aortic cannula and promptly institution of cpb.Post-extubation, the patient was fully alert without any neurocognitive dysfunctions.The rest of the course was uneventful, and the patient was discharged on the 10th postoperative day.The authors noted that the patient developed repeated lv distensions and cardiac arrests, even after repeated successful weaning from the cpb.Tee was used to confirm any unnoticed congenital anomalies like patent ductus arteriosus (pda), atrial septal defect (asd), coartation of the aorta, extra ventricular septal defect (vsd) and vsd patch closure.After exclusion of the other possible causes of lv dysfunction and cardiac arrests, finally they reached to the decision that the repeated episodes of cardiac arrests were related to the rarer complication, the aortic blood flow obstruction by the aortic cannula.

• Brand Name: PEDIATRIC ONE PIECE ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 15769654
• MDR Text Key: 303395463
• Report Number: 2184009-2022-00294
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K024069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

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: 77012
• Device Catalogue Number: 77012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/10/2022
• 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
• Patient Age: 1 YR
• Patient Sex: Male
• Patient Weight: 6 KG