MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY CONE REMOVAL SYSTEM; VENA CAVA FILTER REMOVAL SYSTEM

Catalog Number RC15

Device Problems Bent (1059); Material Separation (1562); Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been received and an 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 retrieval procedure, the recovery cone was used off label to retrieve the vena cava filter and the polyurethane cone allegedly became torn.The recovery cone captured the filter and the recovery cone, filter and sheath were removed as a single unit.No additional devices were required.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, the subassemblies, the manufacturing process and the 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 complaint reported to date for this failure mode.Visual evaluation: the device was received in two segments.The shaft was inside the sheath with the removal cone protruding out the distal end of the sheath.The handle was returned detached.The sheath tip was flared and the proximal end of the sheath was bunched in appearance as a result of the retrieval attempt.Four of the cone's prongs were separated from the polyurethane.Two of the separated prongs were bent.No other anomalies were noted.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 complaint investigation is confirmed for a detached shaft, material separation, and two bent prongs.It should be noted that per the reported event, the recovery cone was used to retrieve a denali filter.Per the denali ifu (instructions for use), the denali filter should be removed using an intravascular loop snare only.The recovery cone is only indicated 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.The recovery cone is not indicated for use to remove a denali filter.Therefore, it is likely that user related issues (use of a recovery cone to remove a denali filter) contributed to the reported event.Labeling review: recovery cone: the current ifu (instructions for use) states: 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: denali ifu: warning: remove the denali filter using an intravascular loop snare only.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.

• Brand Name: RECOVERY CONE REMOVAL SYSTEM
• Type of Device: VENA CAVA FILTER REMOVAL SYSTEM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5296013
• MDR Text Key: 34136769
• Report Number: 2020394-2015-02008
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: RC15
• Device Lot Number: GFZG3625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 167