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

Catalog Number DL950J

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

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 jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified.(expiry date: 03/2023).Device pending return.

Event Description

It was reported that prior to a filter placement procedure in the inferior vena cava to treat deep vein thrombosis through puncture in jugular vein, the operator noted that the filter clip that has to be used to fasten allegedly fell off.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 jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system 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 jugular denali filter was returned for evaluation.The filter was noted within the storage tube and the pusher catheter was received within the touhy adapter.The filter snare hook was noted to be detached from the pusher hook within the storage tube.The pusher catheter was used to deploy the filter from the storage tube; all limbs are present and uncrossed.No skiving or bowing were noted to the storage tube.Based on the findings, the investigation is confirmed for the reported device dislodged issue as it was noted that the filter hook was detached from the pusher hook within the storage tube.A definitive root cause for the reported device dislodged 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: (expiry date: 03/2023).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.

Event Description

It was reported that prior to a filter placement procedure in the inferior vena cava to treat deep vein thrombosis through puncture in jugular vein, the operator noted that the filter clip that has to be used to fasten allegedly fell off.The procedure was completed using another device.There was no patient contact.

• 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: 12757527
• MDR Text Key: 280459925
• Report Number: 2020394-2021-01941
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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: GFEQ2373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG