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

Model Number	SP-4094-002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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
It was reported that during a vena cava filter retrieval procedure, the front end of the loop line was allegedly loosening off.The procedure was completed using another device.There was no reported patient injury'' '(b)(6) 2025 - it was originally reported in the event description, "patient was admitted to the hospital for lower extremity deep vein thrombosis, performed "percutaneous inferior vena cava filter removal", selected model srk35 filter recycler, the operator's operating standards, in the process of sending into the body of the operation occurs at the front end of the loop line loosening off, failed to operate to take out the filter; overall after removing the filter, a new one was used for the operation, and the operation went smoothly, but the operator suspected that there was a product quality mode, and requested to file a complaint and report the damage." the event description was modified for clarity.The device is available for return.Confirmed event date was prior to expiration date in jde.Expiration date for lot 9017299808 is 04/23/2027.A follow up task child was created and assigned to the ibc requesting additional patient and procedural details''.(b)(6).

• Brand Name: BARD SNARE OUS
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS LLC; 5030 centerville road; st. paul 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 55127
• MDR Report Key: 21860698
• Report Number: 3008988055-2025-00003
• Device Sequence Number: 17323880
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: 00857834006551
• 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
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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
• Device Model Number: SP-4094-002
• Device Catalogue Number: SRK35
• Device Lot Number: 9017299808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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