MAUDE Adverse Event Report: OKAMI MEDICAL INC. SENDERO MICROCATHETER; CATHETER, PERCUTANEOUS

Model Number	SENDERO-MC29-130
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the reported issue was found prior to being used on a patient and no injury occurred, the reported unsealed inner sterile pouch represents a failure of the sterile barrier system and constitutes a device malfunction.A breach of the sterile barrier could result in loss of sterility and potential microbial contamination of the device.A review of all available complaint data identified no additional or similar reports of sterile barrier failures the investigation activities into this complaint are ongoing and further updates will be provided as necessary.
Event or Problem Description
A representative reported that upon opening the shelf carton of a sendero 2.9 microcatheter, the inner sterile pouch was found open and unsealed.

• Brand Name: SENDERO MICROCATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): OKAMI MEDICAL INC.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): OKAMI MEDICAL INC.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer Contact: cora sim ; 8 argonaut; suite 100; aliso viejo, CA 92656 ; 9494469710
• MDR Report Key: 25541349
• Report Number: 3016444913-2026-00011
• Device Sequence Number: 15861516
• Product Code: DQY
• UDI-Device Identifier: 00850008222078
• UDI-Public: 01008500082220781025E000817251121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: Other
• Device Expiration Date: 11/21/2025
• Device Model Number: SENDERO-MC29-130
• Device Lot Number: 25E0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown