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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Edema (1820); Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 01/23/2014
Event Type  malfunction  
Event Description
It was reported that sometime post filter deployment (date not provided), allegedly the filter penetrated the retroperitoneum, the filter was retrieved successfully. No other pertinent patient, device or medical information was provided leading up to or surrounding the event. The patient status at this time is unknown.
 
Manufacturer Narrative
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. The device was not returned for evaluation. Images and medical records were not provided for review. Therefore, the investigation is inconclusive for perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. A review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate. (expiry date: 05/2011), (manufacturing date: 05/2008).
 
Manufacturer Narrative
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 device was not returned. Images and medical records were not provided. The investigation is inconclusive for perforation of the ivc wall. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: - perforation or other acute or chronic damage of the ivc wall. 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 sometime post filter deployment (date not provided), allegedly the filter penetrated the retroperitoneum, the filter was retrieved successfully. No other pertinent patient, device or medical information was provided leading up to or surrounding the event. The patient status at this time is unknown.
 
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Brand NameG2 FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key6153247
MDR Text Key285810678
Report Number2020394-2016-01136
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFSD2849
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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