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

Model Number	SRK35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a filter was placed in the vein of the lower extremity of the patient where there was thrombus.When the filter was retrieved with the snare retrieval kit, the marker for visualization at the proximal catheter of the kit fell into the postcava wall of the patient, which could not be removed.The director of the hospital notified the patient of this event and future operation will depend on the conditions of the patient.It was reported that during a filter removal procedure, the marker allegedly detached.There was no reported patient injury.
Additional Manufacturer Narrative
Date of this report (b)(6) 2021.

• Brand Name: BARD
• Common Device Name: SNARE RETRIEVAL KIT
• 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 guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 12728642
• Report Number: 3008988055-2021-00001
• Device Sequence Number: 4641364
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)230923(10)9006545299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152560
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 09/06/2021

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: 09/23/2023
• Device Model Number: SRK35
• Device Catalogue Number: SRK35
• Device Lot Number: 9006545299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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 Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG