Model Number 0684-00-0479-07 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/02/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
|
|
Event Description
|
It was reported that during insertion of an intra-aortic balloon (iab), a defect was noticed near the tip of the iab.The iab was then changed out with a new one.There was no patient harm or adverse event reported.
|
|
Event Description
|
It was reported that during insertion of an intra-aortic balloon (iab), a defect was noticed near the tip of the iab.The iab was then changed out with a new one.There was no patient harm or adverse event reported.
|
|
Manufacturer Narrative
|
Additional information serial # (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Complaint record id # (b)(4) h3 other text : device not returned.
|
|
Manufacturer Narrative
|
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
The product was returned with the membrane loosely unfolded with traces of blood on the outside of the catheter.No physical damaged noted.A visual examination of the entire device was performed and no kinks or damage was detected near, or at the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 to nov-20 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
|
|
Search Alerts/Recalls
|