MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96880-025

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Respiratory Failure (2484); Blood Loss (2597)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use, the customer reported bio-medicus multistage femoral venus cannula split during removal and they had to cut down the percutaneous insertion to expose the vessel to make removal easier.The product was replaced.The customer estimates the patient lost approximately 1liter of blood.The patient was on vv ecmo, stable but still critical due to the underlying respiratory failure.The split cannula section is still in the patient.Additional information: an emergency cannulation was performed during which a multistage femoral venous cannula was percutaneously inserted into the patients groin to provide venous drainage.The cannulation procedure involved dilating the vessel which passed without event.Upon inserting the cannula over the guidewire the clinician met resistance introducing the cannula.The customer hypothesizes that perhaps there was an issue passing the pelvic bone.The clinician attempted to pull back the cannula to try to re-insert/reposition, but it would not come back out of the vessel.It was lodged in the vessel.Blood loss occurred from the cannula connector end from the guidewire hole in the introducer, and also from the cannulation site on the patient.The customer estimates that approximately 1liter of blood was lost, perhaps more.The clinical team deduced that the cannula had actually been inserted into the femoral artery instead of the femoral vein.Hypothesizing that because saturations were low the blood was not easily identifiable as venous blood.Within 10 minutes a consultant cardiac surgeon removed the cannula using ¿some force¿.The cannula ¿split¿ leaving a section of the cannula in the patient.The cardiac surgeon had cut down the percutaneous insertion so they could expose the vessel to make removal easier.Upon pulling back on the cannula the surgeon could see that the inner wall of the vessel was also pulling back (confirming the cannula was lodged quite firmly).The patient was then put on vv ecmo using the jugular for drainage and the femoral vein to return blood to the right atrium (the other groin was used for this cannulation).The patient arrested whilst on vv ecmo.Patient was then put on vva ecmo to improve the patient¿s condition.The patient is stable but still critical due to the underlying respiratory failure.The split cannula section is still in the patient.The patient does have some flow down their leg (confirmed by doppler / nirs) but their legs are in some difficulty (ischemic limbs).Customer cannot confirm if the leg issues are due to the cannula or previous hypoxic / respiratory critical illness.Vascular surgeons have been consulted regarding the cannula section removal.

Manufacturer Narrative

Visual inspection of the section returned shows it is damaged/split.Device was cleaned using a 10% bleach solution.Additional visual inspection shows the porous plug is broken.Conclusion; there is a potential this was caused by an incorrect use of the cannula as a 25 fr was used in a 15 year patient with 56 kg, according to clinical affairs representative, that size of cannula is too big, the most appropiate size is a 17 fr cannula the resident should have cannulated the vein, instead they cannulated the artery the device history record could not be reviewed as no lot number was provided.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: BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9382426
• MDR Text Key: 168780631
• Report Number: 2184009-2019-00077
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K052524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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: 96880-025
• Device Catalogue Number: 96880-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 56