MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 77208 ART ONE PIECE 8FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 77208

Device Problems Increase in Pressure (1491); Material Puncture/Hole (1504)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of a dlp pediatric one-piece arterial cannula, it was reported that a 5 day old patient was admitted for transposition of the great vessels and during the bypass procedure, the cannula pressure was very high though the maximum flow had not been reached.The device was removed by the physcian during the operation and noticed a shear caused by the purse string suture.The device was replaced to complete the procedure.There was no adverse patient effect reported with this event.

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.

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of any damage.During the cleaning process there was no blockages observed, there was flow through the device.Reason for return was undetermined.Additional information b.5 medtronic received additional information that there was no damage to the packaging (outer box, inner packaging or sterile barrier).There were no other devices in the same box/shipping container that were damaged.The same insertion site was used when the customer replaced the cannula.There were no adverse patient effects associated with this event.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.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.

Manufacturer Narrative

Conclusion: after investigation, the complaint is unconfirmed for a pressure/blockage issue.Visual inspection of the returned device did observe white lines in the tip end area on the cannula.Additional inspection of the tip area under ten times magnification found what appeared to be several splits/tears, which would be similar to the shearing caused by the suture as stated in the complaint description.Dimensions were taken in the inner diameter (id), outer diameter (od) and length of the tip.Additional dimensions were taken for overall length of the cannula after it was cut and the print from the tip to the first depth mark.Results found the dimensions were all within tolerance.Performance testing indicated that the device functioned as intended.It is unknown what may have caused this occurrence.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A review of complaints received for this model number found no similar occurrences.There were no adverse patient effects because of this incidence.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.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: CANNULA 77208 ART ONE PIECE 8FR
• 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: 17457545
• MDR Text Key: 320392611
• Report Number: 2184009-2023-00874
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000091033
• UDI-Public: 00763000091033
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 10/09/2023

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: 77208
• Device Catalogue Number: 77208
• Device Lot Number: 2022110990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 09/28/2023
• Supplement Dates FDA Received: 09/01/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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 Age: 5 DA