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

Catalog Number DL950J

Device Problems Break (1069); Difficult to Insert (1316); 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 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

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.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2024).

Event Description

It was reported that during a vena cava filter deployment procedure, the catheter shaft was allegedly broken and the outer sheath was damaged.Therefore, the sheath was unable to be inserted.Another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a vena cava filter deployment procedure, the catheter shaft was allegedly broken and the outer sheath was damaged.Therefore, the sheath was unable to be inserted.Another device was used to complete the procedure.There was no reported patient injury.

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 dilator loaded into a introducer sheath was returned for evaluation.Introducer sheath was returned with dilator still inserted inside.Dilator distal tip was damaged and a bend noted approximately 6.5cm from the distal tip.Damage was also noted near the holes of the dilator approximately 5.8cm from the distal tip.No other anomalies were noted.Based on the findings, the investigation is confirmed for the reported material deformation and the identified deformation due to compressive stress issues as damage was noted near the holes of the dilator and the dilator distal tip deformation.However, the investigation is inconclusive for the reported break and difficult to insert issues as a reported event cannot be reproduced.A definitive root cause for the reported difficult to insert, break, material deformation 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: 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: d4(expiry date: 01/2024), g3.H11: h6(device, result and conclusion).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.

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 dilator loaded into a introducer sheath was returned for evaluation.Dilator distal tip was damaged and a bend noted approximately 6.5cm from the distal tip.Damage was also noted near the holes of the dilator approximately 5.8cm from the distal tip.Based on the findings, the investigation is confirmed for the reported material deformation and the identified deformation due to compressive stress, material bend issues.However, the investigation is inconclusive for the reported break and difficult to insert issues.A definitive root cause for the reported difficult to insert, break, material deformation and the identified deformation due to compressive stress, material bend 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: 01/2024), g3, h6(device).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.

Event Description

It was reported that during a vena cava filter deployment procedure, the catheter shaft was allegedly broken and the outer sheath was damaged.Therefore, the sheath was unable to be inserted.The procedure was completed using another device.There was no reported patient injury.

• 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: 12421457
• MDR Text Key: 269795401
• Report Number: 2020394-2021-01572
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/25/2022

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: GFFP0434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 11/10/2021; 03/04/2022
• Supplement Dates FDA Received: 12/06/2021; 03/07/2022
• 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