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Catalog Number IAB-S840C |
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 10/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath.The swg was deformed, and the balloon was damaged.Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work.There was no patient death or serious injury or reported.Patient current condition reported as fine.
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Event Description
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It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath.The swg was deformed, and the balloon was damaged.Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work.There was no patient death or serious injury or reported.Patient current condition reported as fine.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of insertion difficulty is not able to be confirmed.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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