Model Number IPN000263 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).For related complaint on the same patient and event see mdr #3010532612-2019-00358 and (b)(4).
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Event Description
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It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
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Event Description
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It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
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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 central lumen occluded 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.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.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc # (b)(4).
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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 of central lumen occluded 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.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.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc #(b)(4).The complaint was reopened to investigate the device that was returned to teleflex.The reported complaint of central lumen occluded is not confirmed.During functional testing, no blockage or occlusion was noted.The returned device passed functional test specifications.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.No further action required at this time.
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Event Description
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It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
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Search Alerts/Recalls
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