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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the two reported malfunctions was provided, and lot history reviews were performed.The devices for both malfunctions were not returned for evaluation; however, medical records were provided and reviewed.For one of the two reported malfunctions, the investigation is confirmed for perforation and tilt.The investigation for the second malfunction is confirmed for perforation; however, is inconclusive for 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 tilt and perforation.This information was received from various sources.This malfunction involved two patients with no consequences.One patient is a (b)(6) year old male and weighed (b)(6) lbs and the other is a (b)(6) year old female.The weight of second patient was unknown.

• 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: 11227122
• MDR Text Key: 228785120
• Report Number: 2020394-2021-80128
• 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: 01/25/2021

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: GFOJ0969, GFPD4699
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/25/2021
• Type of Device Usage: N
• Patient Sequence Number: 1