MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP METAL TIP ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	80120
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
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 80120 dlp metal tip arterial cannula, the customer observed that the metal tip dissociated from the plastic during decannulation.The tip was recovered without harm to the patient.Bleeding during the case was observed but not very notable.No blood transfusion was required due to blood loss.The tip fully detached as the cannula was almost already out of the patient.It was near the surface of the incision and the physician removed it using their hands.The device was replaced.There was no patient impact associated with this event.There was no damage noted to the device packaging.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the tip is separated from the cannula body.Reason for return was confirmed.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.
Additional Manufacturer Narrative
Investigation conclusion: complaint is confirmed for tip falling off the cannula body.This complaint is the result of a supplier manufacturing issue.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.Supplier evaluation summary: visual inspection verified the tip is separated from the adapter on the returned device.Additional inspection of both the tip and adapter under the microscope found there was no appearance of a uv solvent bond.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: DLP METAL TIP ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN
• MDR Report Key: 12120021
• Report Number: 2184009-2021-00053
• Device Sequence Number: 4723108
• Product Code: DWF
• UDI-Device Identifier: 00613994742537
• UDI-Public: 00613994742537
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K840002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2021

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 Model Number: 80120
• Device Catalogue Number: 80120
• Device Lot Number: 2020091073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 08/12/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/10/2021; 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1