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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for the perforation of the inferior vena cava, material deformation and malposition of the filter.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

A review of the reported information indicates that model rf048f vena cava filter allegedly experienced perforation, malposition of device and material deformation.The information was received from a single source.One patient was involved with no reported patient injury.The female patient is (b)(6) years old and weight was not provided.

• Brand Name: RECOVERY FILTER 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: 11712422
• MDR Text Key: 247010448
• Report Number: 2020394-2021-80383
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

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: No Information
• Device Catalogue Number: RF048F
• Device Lot Number: 07JN0163
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/22/2021
• Type of Device Usage: N
• Patient Sequence Number: 1