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

Model Number	SRK30
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.Once complete, a supplemental report will be filed.
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: 9506141
• Report Number: 2315342-2019-00005
• Device Sequence Number: 3363809
• Product Code: MMX
• UDI-Device Identifier: 00857834006544
• UDI-Public: 00857834006544
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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 Expiration Date: 03/07/2022
• Device Model Number: SRK30
• Device Lot Number: PL06295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 145