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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided for the two malfunctions, therefore a lot history review could not be performed.The devices were not returned for either malfunction however medical records were received.The investigation for one malfunction is confirmed for alleged retrieval difficulties and tilt.The other malfunction is confirmed for retrieval difficulties but is inconclusive for tilt.Based upon the available information, the definitive root cause for this event 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 tilt and unable to retrieve.This information was received from various sources.This two malfunctions involved a patient with no consequences.The 2 patients ranged from 42-56 years of age and the weight was not provided.Of the reported patients, one was male and one was female.

• 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: 10305100
• MDR Text Key: 199846164
• Report Number: 2020394-2020-04769
• 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: 07/21/2020

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 Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1