Catalog Number 1012450-20 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/31/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
|
|
Event Description
|
It was reported that during removal of the 3.25x20 mm nc trek balloon dilatation catheter (bdc), the shaft separated near the hub.The separated portion was able to be pulled out of the anatomy.Another bdc was used to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulty appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
|
|
Search Alerts/Recalls
|