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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number DL950F
Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
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 return of the sample is pending.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 femoral system products that are cleared in the us.The pro code and 510 k number for the denali femoral system products are identified.(expiry date: 07/2023).
 
Event Description
It was reported that during the filter deployment procedure, the filter was allegedly unable to be pushed out of the introducer sheath completely.It was further reported that the filter was removed from the patient along with the sheath and found that the filter bent.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during the filter deployment procedure, the filter was allegedly unable to be pushed out of the introducer sheath completely.It was further reported that the filter was removed from the patient along with the sheath and found that the filter bent.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510 k number for the denali femoral system products are identified in d2 and g4.H10: 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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023), g3, h6 (method).H11: h6 (result and conclusion).H11: section a through f ¿ the information provide by bd represents all 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.Device not returned.
 
Event Description
It was reported that during the filter deployment procedure, the filter was allegedly unable to be pushed out of the introducer sheath completely.It was further reported that the filter was removed from the patient along with the sheath and found that the filter and introducer sheath were bent.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510 k number for the denali femoral system products are identified in d2 and g4.H10: 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 femoral denali filter kit was returned for evaluation.The dilator tip appeared to be damaged and a kink also noted to the introducer sheath approximately 20.0cm from the distal tip, filter was noted to be stuck within the sheath.Skiving to the storage tube and no bowing noticed.The filter was removed from the introducer sheath, all legs were present and noted three legs crossed, all legs are present.The pusher wire was noted to be bent from the pusher catheter.Based on the findings, the investigation is confirmed for the reported failure to advance, material deformation, the identified deformation due to compressive stress and material bent issues as the filter was noted to be stuck within the sheath , a kink and the distal tip deformation noted to the dilator and the pusher wire was noted to be bent from the pusher catheter.A definitive root cause for the reported failure to advance, material deformation, the identified deformation due to compressive stress and material bent 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.H10: b5, d4 (expiry date: 07/2023), g3, h6 (device).H11: h6 (method, result).H11: section a through f ¿ the information provide by bd represents all 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 FEMORAL SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12032507
MDR Text Key257247221
Report Number2020394-2021-01230
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950F
Device Lot NumberGFEU2308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Date Manufacturer Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
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