MAUDE Adverse Event Report: PERFUSION SYSTEMS OCTOPUS EVOLUTION AS TISSUE STABILIZER; STABILIZER, HEART

Model Number	TS2500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of this octopus tissue stabilizer, the customer reported that when they took the device out of it's packaging, they noted that head was separated from the body.The device was replaced for the procedure.There was no patient involvement so no adverse effect occurred.Medtronic received additional information that there was no damage to the packaging.
Additional Manufacturer Narrative
Pma / 510(k) #: device is class i exempt.Device evaluation summary: visual inspection shows the head-link is separated from the device and the protective sheath is missing.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: after investigation the root cause for the head-link separation could not be determined.It was determined that this was not a manufacturing issue as the collet and head-link passed all visual and dimensional quality checks required.The issue appears to have been due to an issue with shipping and storage.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.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 EVOLUTION AS TISSUE STABILIZER
• Common Device Name: 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: 14159179
• Report Number: 2184009-2022-00083
• Device Sequence Number: 12201217
• Product Code: MWS
• UDI-Device Identifier: 00643169668904
• UDI-Public: 00643169668904
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 01/31/2023
• Device Model Number: TS2500
• Device Catalogue Number: TS2500
• Device Lot Number: 2020011013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2020
• 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