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

Catalog Number RC15

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The facility rep has stated that the device is available for evaluation.A sample return kit was sent to the facility and is pending return.The results of the device evaluation will be furnished upon completion of the event investigation.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 the marker band allegedly detached from the sheath of the vena cava filter removal system during retraction through the access site.The detached marker band was successfully captured and retrieved with forceps.There was no reported consequence to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Visual evaluation: the recovery cone removal system was returned.The cone was received inserted through the retrieval sheath.The distal marker band was returned detached from the sheath.The detached marker band was not circular in nature and appeared to be in a linear configuration.The retrieval sheath was noted to be torn longitudinally from the distal tip.The tear was noted to be 2.6cm in length.Skiving was identified at and above the tear for an additional 4.0cm.The detached marker band configuration and tear in the retrieval sheath were most likely do to the high tension and force associated with attempting to retrieve the denali filter through a sheath that was too small.The distal end of the introducer sheath was examined under microscopic magnification.The distal marker band impression was identified at 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.Functional/performance evaluation: no functional testing was performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the recovery cone removal system was returned for evaluation.The distal marker band was returned separated from the retrieval sheath.Therefore, the investigation was confirmed for a detached marker band.Additionally, evaluation found the retrieval sheath to be torn at the distal end, confirming the investigation for torn material.It should be noted that per evaluation results, 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 and the identified torn retrieval sheath.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

It was reported that the marker band allegedly detached from the sheath of the vena cava filter removal system during retraction through the access site.The detached marker band was successfully captured and retrieved with forceps.There was no reported 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: 5811021
• MDR Text Key: 50075432
• Report Number: 2020394-2016-00667
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: RC15
• Device Lot Number: GFZI1380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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