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

Model Number	SRK30
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The patient in this report was a middle aged female with history of deep vein thrombosis (dvt) and she was morbidly obese."when trying to remove the bard inferior vena cava (ivc) filter with the bard retrieval snare the snare broke inside the patient.All pieces were retrieved from the patient" snare was inserted and the hook of the filter was captured and carefully lined in a straight line.Inner sheath was advanced over the proximal hook and filter and advanced approximate 1 cm and would not go any further.Outer sheath was taken over and multiple attempts were made to pass the sheath system in combination and singly over the filter with back pressure on the snare.This was attempted multiple times with multiple passes in the snare burst.Snare and its components were then carefully removed along with the first set of sheaths and a second retrieval system was opened and placed over the wire and a new snare was brought down and the snare was used to grab the hook and again multiple attempts were made to pass the new system over top of the filter collapsing it in good back pressure was again applied.This would not budge the filter would not collapse.With this information snare was then released with some difficulty and sheaths were removed pressure was held over the neck and the patient was discharged recovery in stable condition to have the site monitored and to be discharged home to follow-up in the office.

• Brand Name: BARD SNARE RETRIEVAL KIT
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane north; suite j; plymouth MN 55447
• MDR Report Key: 9346954
• Report Number: 9346954
• Device Sequence Number: 19516619
• Product Code: MMX
• UDI-Device Identifier: 00857834006544
• UDI-Public: (01)00857834006544(17)220307(10)PL06295
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/25/2019
• Report Date (Section F): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SRK30
• Device Lot Number: PL06295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1
• Patient Weight: 145
• Date Report Sent to FDA: 10/25/2019