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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
Model Number DL900J
Device Problems Break (1069); Material Discolored (1170); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: one jugular denali filter kit was returned for evaluation. Filter was in storage tube along with the pusher rod. Introducer sheath was bloody. Dilator was returned inside the introducer sheath and noted the introducer sheath to have cracks, splits and missing gaps distal to the tip of the dilator. In addition, dry contrast was observed in the areas of the cracks, splits and missing gaps on the introducer sheath. Skiving was also noted to the storage tube. Dilator tip was noted to be damaged. Filter was removed from the storage tube by using a pusher catheter, some resistance was noted during the removal. All limbs are present and uncrossed. Based on the findings, the investigation is confirmed for the reported break and identified deformation due to compressive stress and failure to advance issues as it was noted the cracks, splits and a missing gaps on the introducer sheath, dilator tip was noted to be damaged and some resistance was noted during the removal of filter from storage tube. Although the sample was returned, one electronic photo was provided and reviewed. The photo shows the partial part of the introducer sheath. The visible portion of the device noted with the cracks, splits and missing gaps on the sheath. The dilator can be noted within the sheath. Therefore, based on the photo review, the reported break issue can be confirmed. A definitive root cause for the reported break and identified deformation due to compressive stress, failure to advance issues 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: 12/2021).
 
Event Description
It was reported that prior to a filter placement procedure, the distal tip of sheath was allegedly disintegrated in physician's hands. The procedure was completed using another device. There was no patient contact.
 
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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 Key12306728
MDR Text Key265993976
Report Number2020394-2021-01468
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFCY1584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2018
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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