MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS BARD SNARE DUAL SHEATH SNARE KIT, 20 MM; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	SP-4094-001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a filter retrieval procedure, the device allegedly broke off in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
They were able to retrieve the filter but not the catheter tip on the snare removal device that broke off.The tip was left in the patient as there was no viable way to retrieve it.I have not received an update from the customer but will check if there was any follow up.

• Brand Name: BARD SNARE DUAL SHEATH SNARE KIT, 20 MM
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• 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: 13867934
• Report Number: 3008988055-2022-00002
• Device Sequence Number: 4692526
• Product Code: MMX
• UDI-Device Identifier: 00857834006544
• UDI-Public: (01)00857834006544(17)240112(10)9007027211
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: SP-4094-001
• Device Catalogue Number: SRK30
• Device Lot Number: 9007027211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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