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

Catalog Number FBRC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not 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

During a vena cava filter retrieval procedure, it was reported that the marker band detached from the sheath of the cone retrieval device and traveled to the right atrium.A consulting interventional radiologist recommended leaving the marker band in place as the patient was asymptomatic.There was no known 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: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the detached marker band as no objective evidence has been provided to confirm any alleged deficiency with the recovery cone.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 alleged marker band detachment.However, the definitive root cause is unknown.Note: the sales representative performed an in-servicing with the health care provider on the proper methods and equipment required to successfully retrieve a denali filter.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 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

During a vena cava filter retrieval procedure, it was reported that the marker band detached from the sheath of the cone retrieval device and traveled to the right atrium.A consulting interventional radiologist recommended leaving the marker band in place as the patient was asymptomatic.There was no known impact or consequence to the patient.

• 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 Key: 6556092
• MDR Text Key: 74789835
• Report Number: 2020394-2017-00429
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152136
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: FBRC
• Device Lot Number: GFBN0268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 108