MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL

Catalog Number MD800F

Device Problem Physical Resistance (2578)

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

Event Date 02/12/2013

Event Type  malfunction  

Manufacturer Narrative

A further review of this event was performed and identified a change in the mdr reportability pursuant to 21 cfr part 803.No device and no medical records have been made available to the manufacturer.Medical images have been provided for evaluation.As the lot number for the device has not been provided, 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.Device not returned.

Event Description

It was reported that during a scheduled vena cava filter retrieval, increased resistance and difficulty was experienced during the capture of the vena cava filter inside the sheath.The filter was captured and retrieved successfully.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: - a manufacturing review could not be conducted as the lot number is reportedly unknown.Visual/microscopic inspection: - the device was not returned; therefore, inspection could not be performed.Functional/performance evaluation: - the device was not returned; therefore, evaluation could not be performed.Medical records review: - as medical records were not provided, a review could not be performed.Image/photo review: - one image was provided and reviewed.Based on the image review, the complaint investigation is inconclusive for the reported filter removal difficulties.Conclusion: - per the reported event, the physician reported that the apex of the filter went into the sheath without difficulty; although, the shoulders of the filter did not want to collapse and go into the sheath.It is unknown if patient and/or procedural factors contributed to this event.Based upon the available information the definitive root cause for the event is unknown.Labeling review: - the current ifu (instructions for use) states: warnings: do not attempt to remove the meridian filter if significant amounts of thrombus are trapped within the filter or if the retrieval hook is embedded within the vena cava wall.Remove the meridian filter using an intravascular snare and 10 french i.D.Retrieval sheath only.Refer to the optional procedure for filter removal section for details.Optional procedure for filter removal: slowly advance the loop forward over the filter apex.Reduce the loop diameter by advancing the snare catheter while simultaneously pulling the snare backwards until the loop engages the filter retrieval hook.Note: under fluoroscopic guidance, ensure that the loop of the snare has properly engaged the retrieval hook and that the retrieval hook, retrieval catheter and snare are aligned.Caution should be employed when using a snare to engage the hook of the filter only, avoiding engagement of filter arms or legs.The marker tip of the snare catheter must be cephalad to the filter retrieval hook.Note: always maintain tension on the snare to prevent disengagement of the snare loop from the filter retrieval hook.Advance the sheath in the caudal direction until it aligns with the distal tip of the snare catheter.While keeping tension of the snare, hold the retrieval sheath stationary and withdraw the filter into the retrieval sheath by retracting the intravascular snare.Continue retracting the snare until the filter is completely collapsed inside the sheath.Once the filter is fully collapsed inside the sheath, retract the complete system as a unit out through the sheath.Warning: do not attempt to remove the meridian® filter if significant amounts of thrombus are trapped within the filter or if the retrieval hook is embedded within the vena cava wall.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• Type of Device: MERIDIAN FILTER 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: 5036833
• MDR Text Key: 25144674
• Report Number: 2020394-2015-01537
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• 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