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

Catalog Number RF048F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned to bd for evaluation.Medical records were returned and reviewed for both malfunctions.Of the two malfunctions, one investigation is confirmed for retrieval difficulties, filter tilt, and material deformation.One investigation is confirmed for retrieval difficulties and material deformation, but it is inconclusive for filter tilt.Based on the information provided, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced a difficulty to remove, filter tilt, and material deformation.This information was received from various sources.Both malfunctions involved a patient with no patient injury.The patients ranged from 34 to 57 years of age and both were male.Patient weight was not provided.

• Brand Name: RECOVERY 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: 9218682
• MDR Text Key: 163169401
• Report Number: 2020394-2019-04261
• 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): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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: UNKNOWN
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1