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

Catalog Number UNKNOWN FILTER

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); 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 devices were not provided, a lot history review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation; however; medical records were received for both the malfunctions.Therefore, the investigation is confirmed for the reported migration, malposition of device and patient device interaction problem for one malfunction and for another malfunction it is confirmed for patient device interaction problem and it is inconclusive for migration and malposition of device.Based on 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 indicates that model unknown filter vena cava filter allegedly experienced migration, malposition of device and patient device interaction problem.These information's were received from a various sources.Both the malfunctions involved patient with no patient consequences.A (b)(6) years old male patient weighs (b)(6) lbs and a (b)(6) years old female patients weight was not provided.

• Brand Name: NITINOL 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: 10731825
• MDR Text Key: 212973994
• Report Number: 2020394-2020-06053
• 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: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1