MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM; VENA CAVA FILTER

Catalog Number UNK G2X

Device Problem Failure to Capture (1081)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.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: 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 investigation is inconclusive for an unsuccessful retrieval attempt of the vena cava filter.Per the reported event details, the bent recovery cone prongs caused the filter to shift and become irretrievable.It is unknown how the prongs on the recovery cone system became bent.Labeling review: the current ifu (instructions for use) states: warnings: - do not attempt to remove the g2 x filter if significant amounts of thrombus are trapped within the filter or if the retrieval hook is embedded within the vena cava wall.Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.- remove the g2 x filter using an intravascular snare or the recovery cone removal system only.Refer to the optional procedure for filter removal section for details.Precaution: the cone must be fully retracted into the y-adapter before connecting the system to the introducer catheter to ensure that the cone can be properly delivered through the catheter.- attach the male end of the y-adapter with the collapsed cone directly to the introducer catheter.The introducer catheter and the retrieval cone system should be held in a straight line to minimize friction.- advance the cone by moving the pusher shaft forward through the introducer catheter, advancing the cone with each forward motion of the pusher shaft.- continue forward movement of the pusher shaft until the cone advances to the radiopaque marker on the distal end of the introducer catheter.Unsheathe to open the cone by stabilizing the pusher shaft and retracting the introducer catheter.- after the cone has been opened superior to the filter, carefully advance the cone over the retrieval hook 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 retrieval hook.- close the cone over the retrieval hook by advancing the introducer catheter over the cone while holding the pusher shaft stationary.Note: if difficulty is encountered while attempting to engage the retrieval hook and/or multiple passes are required, consider using an intravascular snare as an alternate retrieval method.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.Not returned.

Event Description

It was reported that during a vena cava filter retrieval procedure, the filter was unable to be captured and could not be retrieved.Reportedly, the procedure was abandoned and the patient was referred to a specialist for retrieval of the filter.There was no reported patient injury.

• Brand Name: G2X FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• 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: 5102874
• MDR Text Key: 26720828
• Report Number: 2020394-2015-01634
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK G2X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention