Catalog Number 0684-00-0514 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complete event site name: (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.Complaint record id # (b)(4).
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Event Description
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It was reported that while inserting an intra-aortic balloon (iab) through the sheath, resistance was met while advancing the catheter causing it to be impossible to insert.The iab was replaced to start therapy.There was no patient harm, or adverse event reported.
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Manufacturer Narrative
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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.Reference complaint # (b)(4).Device not returned.
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Event Description
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It was reported that while inserting an intra-aortic balloon (iab) through the sheath, resistance was met while advancing the catheter causing it to be impossible to insert.The iab was replaced to start therapy.There was no patient harm or adverse event reported.
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Event Description
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It was reported that while inserting an intra-aortic balloon (iab) through the sheath, resistance was met while advancing the catheter causing it to be impossible to insert.The iab was replaced to start therapy.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The one-way valve was also returned.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device meets all product specifications.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.Reference complaint #: (b)(4).
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Search Alerts/Recalls
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