MAUDE Adverse Event Report: PERFUSION SYSTEMS OCTOPUS NUVO TISSUE STABALIZER; STABILIZER, HEART

Model Number TSMICS1

Device Problems Mechanical Problem (1384); Material Separation (1562)

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

Event Date 07/08/2020

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of an octopus nuvo tissue stabilizer, the stabilizer headlink couldn't be fixed in the shaft properly.It fell off when attached to the tissue.The device was replaced.There was no patient impact associated with the event.

Manufacturer Narrative

Device evaluation summary: visual inspection shows a tear/damage in the tubing at the head-link connection.The head-link assembly was inserted and removed 3 times with no loose issues noted.Reason for return was undetermined.Conclusion: complaint not confirmed for the octopus nuvo's head-link not fixing properly.Analysis of the returned device was unable to determine an issue inserting the head-link, as the head-link assembly was inserted and removed 3 times with no loose issues noted.However, visual analysis showed evidence of tear/damage in the tubing at the head-link connection, which could have contributed to the issue.Review of this unit's device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and visual inspections during manufacturing.Root cause is unknown.A review of complaints for similar model numbers showed no trends warranting escalation at this time.Trends for issues with this product are reviewed at product quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Continued from g3 pma / 510(k) #: device is class i exempt.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

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: OCTOPUS NUVO TISSUE STABALIZER
• Type of Device: STABILIZER, HEART
• 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: 17105471
• MDR Text Key: 317239343
• Report Number: 2184009-2023-00484
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00643169668959
• UDI-Public: 00643169668959
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: TSMICS1
• Device Catalogue Number: TSMICS1
• Device Lot Number: 2020020681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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