MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) DENALI FILTER; VENA CAVA FILTER

Catalog Number DL950J

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl950j vena cava filter allegedly experienced material puncture and failure to advance.This information was received from one source.The material puncture and failure to advance involved one patient with no patient consequence.The patient was (b)(6) years old and weight was not reported.The reported patient was female.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation, however a photo and video were provided for review.The investigation is confirmed for the reported puncture and failure to advance issue.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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

This report summarizes one malfunction.A review of the reported information indicated that model dl950j vena cava filter allegedly experienced material puncture and failure to advance.This information was received from one source.The material puncture and failure to advance involved one patient with no patient consequence.The patient was 41 years old and weight was not reported.The reported patient was female.

• Brand Name: DENALI FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8813308
• MDR Text Key: 151781106
• Report Number: 2020394-2019-01702
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DL950J
• Device Lot Number: GFCQ2705
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1