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

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	05/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter full address could not fit in cell e1 and is the following: (b)(6) 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
The snare retrieval kit was expected to be used to retrieve the denali filter placed in the inferior vena cava through the right internal jugular vein.When performing radiograph with the 11 f introducer sheath of the retrieval kit, liquid was found leaking the distal end of the introducer sheath.The sheath was removed out of the body and carefully examined and a small "breach" was found.To ensure the safety of the patient during operation, the snare retrieval kit was replaced with a new one.

• Brand Name: BARD SNARE RETRIEVAL KIT
• Common Device Name: PERCUTANEOUS RETRIEVAL DEVICE
• 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: timothy desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 17090973
• Report Number: 3008988055-2023-00004
• Device Sequence Number: 2833473
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)250423(10)9010023491
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2025
• Device Model Number: SP-4094-002
• Device Catalogue Number: SRK35
• Device Lot Number: 9010023491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2022
• 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