MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number CB96570-017

Device Problem Material Separation (1562)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion: after investigation at medtronic, complaint cannot be confirmed for loose hemostasis cap.However, based on the event de scription, there is a potential this was caused following cortiva coating.It has been determined that if the hemostasis cap is placed fully over the protective sheath, the hemostasis cap will stretch.Previously, there were no process steps preventing the placeme nt of the hemostasis cap on the sheath.Notification has taken place with operations and the work instruction is in the process of being updated to prevent future occurrence.Review of the device history record at the supplier found no abnormalities during manufacturing that would cause or contribute to the reported event.There were no adverse patient effects as a result of this incidence.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.

Event Description

Medtronic received information that prior to use of two bio-medicus cannulae, the customer reported that there was gap at the top of the cap on the first cannula.It was stated the defective cap has a larger diameter and a shorter height of 2mm than the normal one.In addition, the gap between the introducer and the hemostatic cap was loosely open, so it seemed that there was a risk of absence.The device was replaced to complete the procedure.There was no patient involvement so no adverse effect occurred.The second device¿s connection between the hemostatic cap and the connector was poor, and there was the same gap issue as the first cannula.The cap of this cannula seemed to come off easily.

• Brand Name: BIO-MEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 17351235
• MDR Text Key: 319494107
• Report Number: 2184009-2023-00838
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142673
• 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
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB96570-017
• Device Catalogue Number: CB96570-017
• Device Lot Number: 221825366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2021
• 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