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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 Difficult to Insert (1316); Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified in section has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us. The pro code and 510 k number for the denali jugular system products are identified. Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: the sample was not returned. However, two electronic photos were provided and reviewed. The first photo shows the deformed filter, storage tube, detached introducer sheath and the tip of the pusher gripper. One deformed filter limb can be noted to the filter. The introducer sheath was noted to be in two detached segments. The detachment was noted immediate next to the introducer hub towards introducer sheath. The second photo shows the filter and one filter limb was noted to be deformed. Therefore, based on photo reviews, the reported material deformation and the identified detachment issues can be confirmed as it was noted that the introducer sheath was detached and a filter limb was deformed. However, based on the photo reviews, the reported difficult to insert and failure to advance issues could not be confirmed. A definitive root cause for the reported difficult to insert, failure to advance, material deformation and the identified detachment 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. (expiry date: 09/2023).
 
Event Description
It was reported that during the filter deployment procedure for the treatment of deep venous thrombosis in both lower extremities through the right internal jugular vein, the filter sheath was allegedly difficult to insert. Allegedly a greater resistance was encountered when the pusher was connected for the advancement of filter. Reportedly, the filter was failed to release despite multiple attempts and found that the filter was allegedly deformed. Therefore, another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameDENALI JUGULAR SYSTEM
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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12390704
MDR Text Key268880194
Report Number2020394-2021-01543
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
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
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL950J
Device Lot NumberGFEW0439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
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

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