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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER Back to Search Results
Catalog Number DL950J
Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2018
Event Type  Injury  
Manufacturer Narrative

  no medical records were provided to the manufacturer. Photos were provided for review. The lot number for the device was provided. The device history record review was completed. The device has been returned. The investigation is currently under way. The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us. The pro code and 510 k number for the denali vena cava filter products are identified respectively. 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 patient was in cardio pulmonary arrest upon arrival, a jugular deployment of a vena cava filter was performed. It was further reported that the sheath allegedly was positioned in the ovarian vein and the filter was partially deployed. Reportedly, the health care provider used the sheath and a snare device to capture the filter and move it into the ivc. Following deployment of the filter in the ivc, a j-tipped guidewire was inserted to adjust the filter when it was allegedly discovered that the filter had migrated into the right atrium as demonstrated by guided fluoroscopy. The patient underwent a thoracotomy to surgically remove the filter. The patient status post procedure was unknown.

 
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Brand NameDENALI VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
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 Key7351613
MDR Text Key102831646
Report Number2020394-2018-00253
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue NumberDL950J
Device LOT NumberGFBQ3074
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/19/2018 Patient Sequence Number: 1
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