MAUDE Adverse Event Report: PERFUSION SYSTEMS PED. ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 77008

Device Problems Increase in Pressure (1491); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 that during use of a dlp pediatric one-piece arterial cannula, the customer reported a potential compromise of the material in the cannula wall approx.5mm from the tip.The customer stated that the canula had been inserted and secured, and cpb initiated and unexpectedly high line pressure was observed in the first 2 minutes of the bypass.The customer adjusted the cannula position and noticed inconsistency in the cannula wall material.The cross clamp was not on and the patient was still being ventilated at the time of the reported event.The customer stated that there was no compromise to the patient.The customer did not notice any damage to the device packaging or any damage during the insertion of the cannula.The device was replaced and the aorta re-cannulated with a new cannula to complete the procedure.There was no adverse patient effect associated with this event.

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of damage/split toward the tip.Reason for return was confirmed.Additional information b5.Medtronic received additional information that the inconsistency appears to be a split in the cannula wall at approximately depth marking 1.There were no clotting issues.As the event happened immediately after going on bypass the customers perfusion records record in minute intervals but if data is crucial the customer can run a specialised report for data every 10 seconds.The customer stated that the procedure was an aortic arch reconstruction, hemoglobin (hb) was 11.2 and haematocrit levels were 34%.The temperature was approximately 30 degrees going on bypass.Expected line pressure of 100-200mmhg by the perfusionist.Full flow target of 200ml/minute due to patient anatomy.The customer experienced immediate intermittent line pressure spikes of 280-290mmhg over approximately 90 seconds on their tyco gauge.The customer had heart and lung machine safety at 280mmhg to ramp down flow and 300mmhg to stop the pump).This was a roller pump case.With this type of patient sometimes high line pressures are expect ed but this intermittent and unusual level was a concern.The customer adjusted the cannula position and noticed inconsistency in the cannula wall material.It was removed and the aorta re-cannulated with a new cannula.The cross clamp was not on and the patient was still being ventilated at the time of the noticed event.There was no compromise to the patient.The customer did not notice any damage to the product packaging or during the insertion of the cannula.The customer is an experienced user of the pediatric one-piece arterial cannula and wonders if there could have been a cannula wall thickness variation or a deviation in the wire winding of the cannula.The customer always keeps the white introducer/obturator in situ whilst cannulating and tying the purse string sutures.6.0 or 7.0 sutures are used to tie the purse string and due to the delicate nature of the small patient¿s tissue, limited force is used to tie the purse string sutures.Once the purse string sutures are tied the sutures are secured using a snugger and silk ties at the 3-4 depth mark on the cannula.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: PED. 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: 18354860
• MDR Text Key: 330875099
• Report Number: 2184009-2023-01088
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000091101
• UDI-Public: 00763000091101
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024069
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77008
• Device Catalogue Number: 77008
• Device Lot Number: 2023040321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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 Weight: 2 KG