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

Model Number DL900J

Device Problems Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2022).Device pending return.

Event Description

It was reported that during the advancement of the filter into the sheath, the filter sheath allegedly torn near the back hub.There was no reported patient injury.

Event Description

It was reported that during the advancement of the filter into the sheath, the filter sheath allegedly torn near the back hub.It was further reported that the patient allegedly experienced bleeding.The current status of the patient is unknown.

Manufacturer Narrative

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.Following components were received: introducer sheath, touhy-borst adapter and filter storage tube.Storage tube was still noted to be attached to the touhy adapter and no skiving or bowing were noted.A tear was noted proximal to strain relief of the introducer sheath, damage was noted to the distal tip of the sheath.No functional testing performed.Based on the findings, the investigation is confirmed for the reported material puncture and the identified deformation due to compressive stress issues as the a tear was noted to the introducer sheath and a distal tip deformation.A definitive root cause for the reported material puncture and the identified deformation due to compressive stress 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: d4 (expiry date: 02/2022), g3, h6 (device).H11: b5, h1, h6 (patient, method, result, 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.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: 12632632
• MDR Text Key: 276426294
• Report Number: 2020394-2021-01875
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFDP0683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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 Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 58 KG