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 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.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 retrieval of a vena cava filter, the radiopaque marker band of the retrieval system allegedly detached and was located in the lung as demonstrated by final fluoroscopy.There was no plan to retrieve the markerband.The patient was reportedly doing well post procedure.

Manufacturer Narrative

The event was reported via medwatch report #mw5066597.Manufacturing review: the device history records were 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 inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: based on the images provided, the distal radiopaque marker band was intact with a uniform density prior to the filter retrieval, can be confirmed.Based on the images provided, the distal radiopaque marker band became separated during the filter retrieval, can be confirmed.Based on the images provided, the radiopaque maker band became detached, can be confirmed.Based on the images provided, the location of the marker band was identified overlying the heart silhouette; although, it is unknown if the detached radiopaque marker band was located in the pulmonary artery or in the heart.Based on the images provided, the removal of the detached marker band cannot be confirmed.Conclusion: the device was not returned.Images were provided and reviewed.Based on the provided images, the investigation was confirmed for a detached marker band.Based upon the available information, the definitive root cause for this event was unknown.It was unknown if patient and/or procedural factors contributed to this event.Labeling review: the current ifu (instructions for use) states: warnings: do not attempt to remove the recovery® filter, recovery® g2® filter or g2® x filter if significant amounts of thrombus are trapped within the filter or if the filter tip is embedded within the vena caval wall.Do not use excessive force when manipulating the cone.Excessive force may damage the catheter or other parts of the recovery cone removal system.If resistance is experienced during the retrieval procedure, check the captured filter and introducer sheath using fluoroscopy.Directions for use: after the cone has been opened superior to the filter, advance the cone over the filter tip by holding the introducer catheter stationary and advancing the pusher shaft.It is recommended to obtain an anterior-oblique fluoroscopic image to confirm that the cone is over the filter tip.Close the cone over the filter tip by advancing the introducer catheter over the cone while holding the pusher shaft stationary.Continue advancing the introducer catheter over the cone until the cone is within the introducer catheter.With the cone collapsed over the filter, remove the filter by stabilizing the introducer catheter and retracting the pusher shaft in one, smooth, continuous motion.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 retrieval of a vena cava filter, the radiopaque marker band of the retrieval system allegedly detached and was located in the lung as demonstrated by final fluoroscopy.There was no plan to retrieve the markerband.The patient was reportedly doing well post procedure.

• 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: 6249733
• MDR Text Key: 64770918
• Report Number: 2020394-2016-01274
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: FBRC
• Device Lot Number: GFYD2720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2014
• 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: 32 YR
• Patient Weight: 81