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

Model Number	SP-4094-002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vena cava filter retrieval procedure, the marker band of the snare at the proximal end allegedly fell off into the vessel.The procedure was completed using another device.There was no reported patient injury.
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: 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 guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 16796438
• Report Number: 3008988055-2023-00003
• Device Sequence Number: 6377867
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)230425(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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown