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

Model Number DL900F

Device Problems Difficult or Delayed Positioning (1157); Failure to Advance (2524); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a lot history review was not performed.The sample was not returned to the manufacturer for inspection/evaluation.Medical records were provided and investigation is confirmed for difficult to deploy, failure to advance, filter tilt and perforation of the ivc.A definite root cause for the reported event could not be determined.The device was labeled for single use.(device code 4001).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900f denali filter allegedly experienced difficult to deploy, failure to advance, perforation and tilt.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old male is unknown.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10287580
• MDR Text Key: 199259866
• Report Number: 2020394-2020-04586
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1