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

Model Number DL900J

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, however, medical records were provided.Per review of the medical records, the investigation confirmed migration.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced migration.This information was received from one source.This malfunction involved one patient with no consequences.The weight of a (b)(6) year old female is (b)(6) pounds.

• Brand Name: DENALI FILTER
• 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: 9973732
• MDR Text Key: 188085845
• Report Number: 2020394-2020-02972
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 04/17/2020

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: No Information
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFZC3709
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1