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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number DL950J
Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified.Expiry date: 08/2023.
 
Event Description
It was reported that prior to a vena cava filter placement procedure, saline was allegedly not coming out from the tip of the dilator after flushing the device.The procedure was completed using another device.There was no patient contact.
 
Event Description
It was reported that prior to a vena cava filter placement procedure, saline was allegedly not coming out from the tip of the dilator after flushing the device.The procedure was completed using another device.There was no patient contact.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one denali filter kit dilator was returned for evaluation.During the visual evaluation, it was observed that the distal tip of the dilator was deformed.The dilator was flushed with water.The water came out from the tip of the dilator without issue.Therefore, the investigation is unconfirmed for the obstruction of flow issue as the water came out from the dilator without issue.However, the investigation is confirmed for the deformation of the distal tip of the dilator, as the distal tip was found to be damaged.One electronic photo was reviewed.The photo shows the distal part of the dilator.It looks like the tip of the dilator was found to be damaged.Although, the tip of the dilator was not clearly visible in the given photo.Therefore, based on the photo review, the reported obstruction of flow can not be confirmed.A definitive root cause for the reported obstruction of flow and identified deformation due to compressive stress issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2023), g3, h6 (device, method) h11: h6 (result, conclusion) h11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.
 
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Brand Name
DENALI JUGULAR SYSTEM
Type of Device
VENA 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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13087312
MDR Text Key282782758
Report Number2020394-2021-02112
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040818
UDI-Public(01)00801741040818
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/10/2022
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 NumberDL950J
Device Lot NumberGFEV1862
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2021
Initial Date FDA Received12/27/2021
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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