Model Number H7493918920200 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 02/26/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that a foreign matter was found inside the sterile pouch.During unpacking of a 2.00mm x 20mm emerge¿ balloon catheter, a hair was found inside the sterile pouch.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: returned product consisted of an emerge balloon catheter with no packaging returned.The device was examined as the packaging was not returned.Inspection of the device revealed no damage or irregularities.The catheter was returned with the product mandrel and balloon protector in place.The attached picture was reviewed and it is inconclusive of what is being shown as it appears to be a metal staple in the picture that is circled.Since the packaging was not returned and the picture does not prove evidence, the reported event was not confirmed.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
|
|
Event Description
|
It was reported that a foreign matter was found inside the sterile pouch.During unpacking of a 2.00mm x 20mm emerge balloon catheter, a hair was found inside the sterile pouch.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|