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

Model Number	96570-117
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a bio-medicus nextgen cannula, it was reported a that the connector was cracked.The device use was unspecified.There was no patient impact associated with this event.
Additional Manufacturer Narrative
Product analysis: visual inspection showed evidence of damage/cracks in the connector.The reason for return was confirmed.Conclusion: after investigation, the complaint is confirmed for a cracked cannula body connector.It is unknown what may have caused this occurrence, however, based on the available information, this complaint is potentially the result of a use-related issue.The damage to the cannula connector can occur when the introducer is inserted into the cannula body without the use of the hemostasis cap.The introducer handle can cause stretching, crazing, or cracking when it is forced into the connector.The hemostasis cap is clear and is attached to the introducer on the provided protective sheath.From the photo provided by the customer, the introducer is in fact inserted into the cannula body without the hemostasis cap, confirming that this is most likely a use-related issue.Trends for issues with this device are monitored.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.

• Brand Name: BIO-MEDICUS NG ARTERIAL CANNULA
• Common Device Name: 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: 14209745
• Report Number: 2184009-2022-00094
• Device Sequence Number: 13904275
• Product Code: DWF
• UDI-Device Identifier: 00643169025776
• UDI-Public: 00643169025776
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Model Number: 96570-117
• Device Catalogue Number: 96570-117
• Device Lot Number: 222539682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown