Catalog Number 1008193-20 |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/13/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that before use, it was noted that the tyvek pouch containing a 5.0 x 20 mm viatrac plus balloon catheter was not sealed and had a tear in the middle.Therefore, the balloon catheter was replaced with an unspecified device to successfully complete the procedure.There was no patient involvement.No additional information was provided.
|
|
Manufacturer Narrative
|
Internal file number - (b)(4).It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported damage to the tyvek pouch.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Search Alerts/Recalls
|