|
Catalog Number EC500F |
Device Problems
Malposition of Device (2616); 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
|
The lot number was provided for 6 out of 10 malfunctions, therefore, lot history reviews were performed.The devices were not returned to the manufacturer for evaluation; however medical records were provided and reviewed for all the ten malfunctions and one of the medical records included images.For 8 of the 10 malfunctions, the investigation is confirmed for perforation and filter tilt.For 2 of the 10 malfunctions, the investigation is confirmed for perforation, but is inconclusive for filter tilt.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(corporate lot no: gfuc2311, gfwd2824, gfvl0179, unknown).
|
|
Event Description
|
This report summarizes ten malfunctions.A review of the reported information indicated that model ec500f vena cava filter allegedly experienced tilt and perforation.This information was received from various sources.All ten malfunctions were involved with no patient consequences.The 10 patients ranged from 41-84 years of age.Of the reported patients, 5 are male and 4 are female.Weight and gender for the remaining patient's were not provided.
|
|
Manufacturer Narrative
|
H10: of the ten reported malfunctions, one was reassessed for reportability and determined to be reportable as a serious injury and was reported under emdr 2020394-2022-90019.H10: the lot number was provided for 5 out of 9 malfunctions, therefore, lot history reviews were performed.The devices were not returned to the manufacturer for evaluation; however, medical records were provided and reviewed for all the nine malfunctions and one of the medical records included images.For 7 of the 9 malfunctions, the investigation is confirmed for perforation and filter tilt.The remaining two malfunctions were confirmed for perforation, but inconclusive for filter tilt.Based on the available information, the definitive root cause is unknown.The devices were labeled for single use.H10: (corporate lot no: gfuc2311, gfvl0179, unknown).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 nine malfunctions.A review of the reported information indicated that model ec500f vena cava filter allegedly experienced tilt and perforation.This information was received from various sources.All nine malfunctions were involved with no patient consequences.Of the reported nine patients, four were male and four were female.Nine patient's ages ranged from 51 to 84 years.All other patient details were not provided.
|
|
Search Alerts/Recalls
|
|
|