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

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.

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.

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 was returned for evaluation.The introducer sheath was received in two segments.The circumferential break of the introducer sheath was noted approximately 1mm from the distal end of the strain relief.Skiving was noted to the storage tube, bowing was noticed.Two electronic photos were provided and reviewed.In the first photo, 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 deformed filter limb in the filter.Based on the findings, the reported material deformation and the identified detachment issues can be confirmed as it was noted that the introducer sheath was detached and a deformed filter limb.However, the investigation is inconclusive for the reported difficult to insert and failure to advance issues as it cannot be reconfirmed.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.H10: d4 (expiry date: 09/2023), g3.H11: h6(method).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.

• 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 Key: 12390704
• MDR Text Key: 268880194
• Report Number: 2020394-2021-01543
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• 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 Number: DL950J
• Device Lot Number: GFEW0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/17/2022
• 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 Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG