Catalog Number D132704 |
Device Problems
Delivered as Unsterile Product (1421); Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that a thermocool® smart touch¿ bi-directional navigation catheter had packaging smashed and damaged upon arrival.It was reported that the top of the white catheter box was damaged and smashed upon arrival.The caller stated that the catheter was not usable.The caller stated that there was some interruption in the catheter's sterile packaging.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
|
|
Manufacturer Narrative
|
It was reported that a thermocool® smart touch¿ bi-directional navigation catheter had packaging smashed and damaged upon arrival.It was reported that the top of the white catheter box was damaged and smashed upon arrival.The caller stated that the catheter was not usable.The caller stated that there was some interruption in the catheter's sterile packaging.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31140972m and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
|
|
Search Alerts/Recalls
|
|