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

Model Number DL900F

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation is confirmed for perforation of the inferior vena cava and filter migration.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900f vena cava filter allegedly experienced migration and patient device interaction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient weight was not provided.

• 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: 10738209
• MDR Text Key: 213183510
• Report Number: 2020394-2020-06123
• 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: 10/26/2020

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: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFXI2523
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/26/2020
• Type of Device Usage: N
• Patient Sequence Number: 1