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

Model Number	SP-4094-002
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2023
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.Device was discarded by user and is not available for evaluation.
Event or Problem Description
It was reported that during a vena cava filter retrieval procedure, when the tungsten-gold ring was pushed out of the retrieval catheter, the marker band allegedly fell onto one arm of the filter.It was further reported that the fallen marker band allegedly could not be retrieved with other alternative methods.Reportedly, gave safety evaluation and comprehensive considerations, the filter was not retrieved for the time being.There was no reported patient injury.
Additional Manufacturer Narrative
The report 3008988055-2023-00012 is being amended to add the correct initial reporter name.

• Brand Name: BARD SNARE RETRIEVAL KIT
• Common Device Name: PERCUTANEOUS RETRIEVAL DEVICE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 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
• MDR Report Key: 18116459
• Report Number: 3008988055-2023-00012
• Device Sequence Number: 7371398
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)250829(10)9010939916
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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
• Device Expiration Date: 08/25/2025
• Device Model Number: SP-4094-002
• Device Catalogue Number: SRK35
• Device Lot Number: 9010939916
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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: Required Intervention
• Patient Sex: Unknown