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

Model Number	SRK30
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a snare retrieval procedure, device allegedly broken inside the patient.It was further reported that the broken pieces were retrieved.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.

• Brand Name: BARD SNARE RETREIVAL 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: timothy desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 17279936
• Report Number: 3008988055-2023-00006
• Device Sequence Number: 3534401
• Product Code: MMX
• UDI-Device Identifier: 00857834006544
• UDI-Public: (01)00857834006544(17)220307(10)PL06295
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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: 03/07/2022
• Device Model Number: SRK30
• Device Catalogue Number: SRK30
• Device Lot Number: PL06295
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2019
• 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: Female
• Patient Weight: 145 KG