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

Catalog Number RF048F

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Of the six devices, three lot numbers were provided and lot history reviews were performed.All the six devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For five malfunctions, the investigations are confirmed for perforation of the inferior vena cava.For the remaining one malfunction, the company is still investigating the issue at this time.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.(corporate lot no: unknown).

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all six patients with no consequences.Six patients' ages were reported to be between 41-67 years, four patients were reported as male, and two patients were reported as female.All other patient details were not provided.

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all six patients with no consequences.Six patients' ages were reported to be between 41-67 years, four patients were reported as male, and two patients were reported as female.All other patient details were not provided.

Manufacturer Narrative

H10: of the reported six malfunctions, lot numbers were provided for three malfunctions and the lot history review were performed.The samples were not returned to the manufacturer for inspection/evaluation; however; medical records were received for all six malfunctions.Therefore, the investigation is confirmed for the reported patient device interaction problem for all six malfunction.Based on the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• MDR Report Key: 11238422
• MDR Text Key: 229147128
• Report Number: 2020394-2021-80134
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: GFOD1329,07JN0163,GFPA0424
• Date Manufacturer Received: 03/30/2021
• Patient Sequence Number: 1