Catalog Number IAB-S840C |
Device Problems
Leak/Splash (1354); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was required.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "guidewire was not inserting properly" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.
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Event Description
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It was reported that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was required.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "guidewire was not inserting properly" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.Other remarks: this complaint has been reopened to investigate the device that has been returned to teleflex for investigation.The reported complaint of iab tight over guidewire is confirmed.The guidewire was not able to fully advance through the central lumen due to a blockage of the central lumen at the bifurcate.The root cause of this complaint is unknown.This complaint is considered isolated, no other inner lumen blockages at the bifurcate site have been reported for this product.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was required.
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Search Alerts/Recalls
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