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

Model Number	LS96218-021
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the bio-medicus life support cannula had normal wire (inquire) that could only be inserted through the intended opening in the cannula under high pressure, suggesting that the lumen in the dilator of the cannula was too small.The wire was pushed 10 cm into the cannula but could not be inserted further and was almost unable to be removed from the cannula.It was noted that the wire did not fit through the cannula, although it was able to fit through a smaller medtronic 19fr.Cannula without any problems.The use of the device was unspecified.There was no patient involved.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of some blockage inside the tip.The introducer id was measured against the specification, with the following results: introducer id was measured to be 0.029 inches the specification has the id to be 0.040 +0.002 / -0.001 inches a 0.038 inch od guidewire was not able to fit inside the tip of the returned cannula.Reason for return was confirmed.Additional information b5.It was reported that the bio-medicus life support cannula had normal wire (inquire) that could only be inserted through the intended opening in the cannula under high pressure, suggesting that the lumen in the dilator of the cannula was too small during use.The wire was pushed 10 cm into the cannula but could not be inserted further and was almost unable to be removed from the cannula.It was noted that the wire did not fit through the cannula, although it was able to fit through a smaller medtronic 19fr.Cannula without any problems.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the issue occurred during the cannulation process (right after putting the guidewire into the introducer).Medtronic received additional information that the device was already in the patient during the cannulation process.However, it was not finished.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction d3: mfr name and postal code updated.Correction d4: unique identifier (udi) # updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIO-MEDICUS LIFE SUPPORT TM
• 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 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21856053
• Report Number: 9612164-2025-01952
• Device Sequence Number: 4719398
• Product Code: DWF
• UDI-Device Identifier: 00763000615444
• UDI-Public: (01)00763000615444(17)260414(10)226365203(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K240534
• 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,Followup,Followup
• Report Date (Section B): 07/16/2025

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: 04/14/2026
• Device Model Number: LS96218-021
• Device Catalogue Number: LS96218-021
• Device Lot Number: 226365203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 07/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/14/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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 Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 99 KG