MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96570-117

Device Problem Difficult to Insert (1316)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of a bio-medicus nextgen cannula, it was reported that the catheter was placed in the patient, but the wire could not enter the catheter.After the customer repositioned a new cannula, everything was fine.The device was replaced to complete the procedure.There was no patient impact associated with this event.Additional information was received that the event occurred during on ecmo.

Manufacturer Narrative

Conclusion: the complaint is unconfirmed for the issue with the wire that could not enter the catheter.An analysis of this occurrence could not be performed without the returned product.After evaluation the cause of this complaint could not be determined.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.There were no adverse patient effects because of this incidence.Trends for issues with this device are monitored.Correction h2: company rep has been selected as a report source.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.

• Brand Name: BIO-MEDICUS NG ARTERIAL CANNULA
• 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: 14184285
• MDR Text Key: 291976570
• Report Number: 2184009-2022-00088
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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: 96570-117
• Device Catalogue Number: 96570-117
• Device Lot Number: 222539683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/15/2022
• Date Device Manufactured: 08/08/2021
• 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