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

Catalog Number DL950F

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the denali femoral system that are cleared in the us.The pro code and 510 k number for the denali femoral system are identified.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: 05/2022).

Event Description

It was reported that during a filter placement procedure through right femoral vein via antegrade approach, the sheath allegedly failed to advance and the filter was allegedly bent.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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: 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.The definitive root cause could not be determined based upon available 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 femoral system that are cleared in the us.The pro code and 510 k number for the denali femoral system are identified in d2 and g4.H10: d4 (expiry date: 05/2022).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 filter placement procedure through right femoral vein via antegrade approach, the sheath allegedly was difficult to be inserted and noted to be bent.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a filter placement procedure through right femoral vein via antegrade approach, the sheath allegedly was difficult to be inserted and noted to be bent.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received and the reportability was reassessed as malfunction.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 femoral denali filter kit was returned for evaluation.Following components were received: dilator, introducer sheath, pusher catheter and touhy-borst adapter.Kink noted to pusher catheter approx.25.5cm from proximal end of the handle.The pusher wire was detached from the pusher catheter and not returned.Kink noted approximately 1.1 cm from the distal to the tip of the pusher catheter.Skiving was noted to the storage tube due to deployment of the filter, and no bowing noted.Damaged tip noted on the dilator.Introducer sheath returned in two segments and a break noted to the distal tip of the sheath.Largest segment measure approximately 45.5cm from the distal tip of the introducer sheath to the break.Second segment measures approximately 9.3 cm from break to proximal hub.Storage tube was removed from introducer sheath segment and upon removal.The filter was noted inside the introducer sheath hub.Attempted to remove the filter but was unsuccessful.Filter remains stuck in the introducer hub.Based on the findings, the investigation is confirmed for the reported material deformation and the identified failure to advance, deformation due to compressive stress, detachment issues as a kink noted to the pusher catheter, skiving was noted to the storage tube and filter remains stuck in the introducer hub, dilator tip noted to be damaged, the pusher wire was detached from the pusher catheter and also the introducer sheath returned in two segments.However, the investigation is inconclusive for the reported difficult to insert issue as proper evidence cannot be provided.A definitive root cause for the reported difficult to insert and material deformation and the identified failure to advance, deformation due to compressive stress, detachment 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 femoral system that are cleared in the us.The pro code and 510 k number for the denali femoral system are identified in d2 and g4.H10: d4 (expiry date: 05/2022), g3, h6 (device).H11: h6 (method, result).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 filter placement procedure through right femoral vein via antegrade approach, the sheath allegedly was difficult to be inserted and noted to be 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 that are cleared in the us.The pro code and 510 k number for the denali femoral system 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 femoral denali filter kit was returned for evaluation.Kink noted to pusher catheter approx.25.5cm from proximal end of the handle and a kink noted approximately 1.1 cm from the distal to the tip of the pusher catheter.Skiving was noted to the storage tube due to deployment of the filter, and no bowing noted.Damaged tip noted on the dilator.Storage tube was removed from introducer sheath segment and upon removal.The filter was noted inside the introducer sheath hub.Attempted to remove the filter but was unsuccessful.Filter remains stuck in the introducer hub.Based on the findings, the investigation is confirmed for the reported material deformation and the identified failure to advance and deformation due to compressive stress as a kink noted to the pusher catheter, filter remains stuck in the introducer hub, dilator tip noted to be damaged.However, the investigation is inconclusive for the reported difficult to insert issue as sufficient evidence cannot be provided.A definitive root cause for the reported difficult to insert and material deformation and the identified failure to advance and deformation due to compressive stress 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: 05/2022), g3.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 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: 12251120
• MDR Text Key: 264275449
• Report Number: 2020394-2021-01408
• 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: 12/10/2021

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: GFDS1075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/23/2021; 09/27/2021; 12/16/2021
• Supplement Dates FDA Received: 08/31/2021; 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: 64 YR
• Patient Sex: Female