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

Model Number	SP-4094-002
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Routinely disinfect the skin and spread sterile drape.After successful local anesthesia with docaine, puncture the right jugular vein using the seldinger method and insert.Contrast catheter, perform inferior vena cava angiography, see the inferior vena cava.The veins are unobstructed, the filter is in good position, and there are no thrombi attached.Install, replace the recovery sheath, position under fluoroscopy, and apply the catcher successfully captured the recovery hook and pushed it forward for recovery sheath, retract the filter into the sheath, and recycle the filter smoothly after withdrawing, the marking tape was found to have fallen off, causing another the image showed that the marker band was lost to the heart, and during the operation bleeding is about 10ml.Press the puncture point for 15 minutes after surgery.Afterwards, the puncture point was bandaged with pressure.The operation went smoothly.The patient felt no discomfort and returned to the ward safely.Saturationdegree 99%, r 19 times, min.
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.

• Brand Name: BARD SNARE RETRIEVAL KIT
• 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
• MDR Report Key: 19120369
• Report Number: 3008988055-2024-00002
• Device Sequence Number: 8312042
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)260125(10)9015010308
• 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): 04/16/2024

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: 01/25/2026
• Device Model Number: SP-4094-002
• Device Catalogue Number: SRK35
• Device Lot Number: 9015010308
• 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: 03/18/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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