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

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 in section 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 device was allegedly stuck on sheath and unable to be pushed out of the introducer sheath.It was further reported that the filter was removed along with the sheath and found that the long sheath was 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.H3 other text : device not returned.

Event Description

It was reported that during the filter deployment procedure, the device was allegedly stuck on sheath and unable to be pushed out of the introducer sheath.It was further reported that the filter was removed along with the sheath and found that the long sheath was 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 device was allegedly stuck on sheath and unable to be pushed out of the introducer sheath.It was further reported that the filter was removed along with the sheath and found that the long sheath was bent.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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.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.Distal tip deformation was noted to the introducer sheath.Skiving was noted to the storage tube, but not bowing noted.The pusher wire was noted to be bent from the pusher catheter.The bent pusher wire could be due to filter advancing difficulties.Noted a kink to the introducer sheath approximately 20.2 cm form the strain relief of the hub.No bends were noted to the dilator, other anomalies noted to the sample.Based on the findings, the investigation is confirmed for the reported material deformation and the identified deformation due to compressive stress, material bent issues as noted a kink and distal tip deformation to the introducer sheath and noted a pusher wire bend.However, the investigation is inconclusive for the reported failure to advance as the filter was not returned for evaluation.A definitive root cause for the reported failure to advance, material deformation and the identified deformation due to compressive stress, 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.D4 (expiry date: 07/2023).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.

Event Description

It was reported that during the filter deployment procedure, the device was allegedly stuck on sheath and unable to be pushed out of the introducer sheath.It was further reported that the filter was removed along with the sheath and found that the long sheath was 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.It consists one dilator, pusher catheter, introducer sheath, introducer radiopaque marker band, filter storage tube, and touhy-borst adapter.Filter was not returned.Sample appeared to have blood residue on the filter storage tube and touhy-borst adapter.Distal tip deformation was noted to the introducer sheath.Skiving was noted to the storage tube, but not bowing noted.The pusher wire was noted to be bent from the pusher catheter.The bent pusher wire could be due to filter advancing difficulties.No bends were noted to the dilator, other anomalies noted to the sample.Based on the findings, the investigation is confirmed for the reported failure to advance and the identified deformation due to compressive stress, material bent issues as skiving was noted to the storage tube, distal tip deformation was noted to the introducer sheath and the pusher wire was noted to be bent from the pusher catheter.However, the investigation is unconfirmed for the reported material deformation issue as no bends were noted to the dilator.A definitive root cause for the reported failure to advance, material deformation and the identified deformation due to compressive stress, 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.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 FEMORAL 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: 12032600
• MDR Text Key: 257442798
• Report Number: 2020394-2021-01231
• Device Sequence Number: 1
• Product Code: DTK
• 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,Followup,Followup
• Report Date: 12/16/2021

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: DL950F
• Device Lot Number: GFEU2308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/12/2021; 09/29/2021; 12/16/2021
• Supplement Dates FDA Received: 07/14/2021; 10/01/2021; 12/20/2021
• 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: 53 YR
• Patient Sex: Female