MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS LLC BARD SNARE OUS; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	SP-4094-002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This submission does not constitute a determination or admission that the device has malfunctioned or that the device was related to a death or injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous inferior vena cava filter retrieval using a snare retrieval kit.During the procedure, the fluid was allegedly leaking.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BARD SNARE OUS
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS LLC; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima building 29; guadalupe, cartago 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6513771655
• MDR Report Key: 23968892
• Report Number: 3008988055-2026-00001
• Device Sequence Number: 18111686
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)270724(10)9017746423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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
• Device Model Number: SP-4094-002
• Device Catalogue Number: SRK35
• Device Lot Number: 9017746423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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