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

Catalog Number RF048F

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Activation Failure (3270)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided and a lot history review could not be performed.The device was not returned for evaluation; therefore the investigation is inconclusive for detachment of device or device component, activation failure including expansion failure, and patient-device incompatibility.Based on the available information, a definitive root cause could not be determined.The device is labeled for single use.(b)(4).

Event Description

This report summarizes 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component (4), activation failure including expansion failure (12), and patient-device incompatibility (14).This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number was not provided and a lot history review could not be performed.The device was not returned for evaluation; therefore the investigation is inconclusive for the alleged malfunction.Based on the available information, a definitive root cause could not be determined.The device is 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.

Event Description

This report summarizes 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component (4), activation failure including expansion failure (12), and patient-device incompatibility (14).This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.

Event Description

This report summarizes 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component, activation failure including expansion failure, and perforation.This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot numbers were not provided and a lot history reviews could not be performed.The devices were not returned for evaluation; therefore the investigation is inconclusive for all the alleged malfunctions.Based on the available information, a definitive root cause could not be determined.The devices are labeled for single use.Sanjeeva p kalva, christos a athanasoulis, chieh-min fan, marcio curvelo, stuart c geller, alan j greenfield, et al (2006).¿recovery¿ vena cava filter: experience in 96 patients.Cardiovasc intervent radiol, 29(4):559¿564.Doi: 10.1007/s00270-005-0271-1.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
• 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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9972954
• MDR Text Key: 188082846
• Report Number: 2020394-2020-02939
• 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,Followup,Followup
• Report Date: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1