MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS CANNULA INSERTION KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96551
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the device is damaged/bent.Reason for return was confirmed.Conclusion: after investigation at medtronic, complaint is confirmed for bend or damage to the guidewire.It is unknown what may have caused this occurrence.The device history record was not reviewed as pictures from manufacturing of this lot numbers show all the guidewires correctly packaged into the inner pouch of this insertion kit; the guidewire is not able to be introduced into the peel pouch in the way that it was bent according to the pictures, this bent should have occurred after manufacturing and after removing it from the peel pouch.Complaints received from june 2020 through april 2022 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.Medtronic 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 or Problem Description
Medtronic received information that prior to use, the customer reported when they opened the bio-medicus nextgen insertion kit they found the guidewire was folded/bent.The device was not used.There was no patient involvement so no adverse effect occurred.

• Brand Name: BIO-MEDICUS CANNULA INSERTION KIT
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16929588
• Report Number: 9617601-2023-00107
• Device Sequence Number: 17876208
• Product Code: DWF
• UDI-Device Identifier: 00763000115982
• UDI-Public: 00763000115982
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K190557
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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: 02/27/2024
• Device Model Number: 96551
• Device Catalogue Number: 96551
• Device Lot Number: 219597467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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