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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY CONE REMOVAL SYSTEM; VENA CAVA FILTER REMOVAL SYSTEM
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BARD PERIPHERAL VASCULAR, INC. RECOVERY CONE REMOVAL SYSTEM; VENA CAVA FILTER REMOVAL SYSTEM Back to Search Results
Catalog Number RC15
Device Problems Detachment Of Device Component (1104); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2016
Event Type  malfunction  
Manufacturer Narrative
No medical records or no images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during a vena cava filter retrieval procedure, the marker band allegedly detached from the sheath of the vena cava filter removal system.The filter and the detached marker band were successfully captured and retrieved.There was no reported impact or consequence to the patient.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: the cone was received inserted through the retrieval sheath.The distal tip of the sheath was buckled.The distal marker band was returned detached from the sheath.The distal end of the introducer sheath was examined under microscopic magnification.The distal marker band impression was identified on the appropriate location on the sheaths' surface.This indicates that the marker band was swaged on the introducer sheath during manufacturing.No other anomalies were identified on the sheath.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no images or photos have been made available to the manufacturer.Conclusion: the recovery cone removal system was returned.The distal tip of the introducer sheath was returned buckled and the marker band was returned detached from the catheter.The investigation is confirmed for a detached marker band and buckled material.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: general information: the recovery cone removal system is intended to percutaneously remove the g2 x filter, g2 express filter, g2 filter, recovery filter or a foreign body as indicated.Indications for use: the recovery cone removal system is intended for use to percutaneously remove the g2 x filter, g2 express filter, g2 filter and the recovery filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system.Warnings: do not use excessive force when manipulating the cone.Excessive force may damage the catheter or other parts of the recovery cone removal system.Equipment required: 12 french dilator, directions for use - g2 x filter, g2 express filter, g2 filter or recovery filter removal.Insert the guidewire and gently advance it to the location of the g2 x filter, g2 express filter, g2 filter or recovery filter for removal.Pre-dilate the accessed vessel with a 12 french dilator.Advance the 10 french introducer catheter together with its tapered dilator over the guidewire and into the vein, such that the tip of the sheath is approximately 3cm cephalad to the filter tip.Note: the introducer catheter has a radiopaque marker at the distal end of the catheter sheath to assist in visualization.Perform a standard inferior venacavogram (typically 30 ml of contrast medium at 15 ml/s).Check for thrombus within the filter.If there is significant thrombus within the filter, do not remove the g2 x filter, g2 express filter, g2 filter or recovery filter.Capture and removal of the g2 x filter, g2 express filter, g2 filter or the recovery filter: the capture of the g2 x filter, g2 express filter, g2 filter or recovery filter is illustrated in - figure 4 a-e: (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during a vena cava filter retrieval procedure, the marker band allegedly detached from the sheath of the vena cava filter removal system.The filter and the detached marker band were successfully captured and retrieved.There was no reported impact or consequence to the patient.
 
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Brand Name
RECOVERY CONE REMOVAL SYSTEM
Type of Device
VENA CAVA FILTER REMOVAL SYSTEM
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5673774
MDR Text Key46200906
Report Number2020394-2016-00460
Device Sequence Number1
Product Code GAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Catalogue NumberRC15
Device Lot NumberGFZG3634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight93
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