Catalog Number CL-07611 |
Device Problem
Decoupling (1145)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2015 |
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 while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
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Manufacturer Narrative
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(b)(4).Evaluation: no product was returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the sidearm detached from the sheath is not able to be confirmed.The root cause of the complaint is undetermined.
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Event Description
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It was reported that while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
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Manufacturer Narrative
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(b)(4) device evaluation: returned for evaluation was a 6fr super arrow-flex (saf) sheath.Upon initial inspection the sidearm was noted not attached to the sheath hub.The sideport did not appear damaged upon visual inspection.The sidearm was able to be completely reattached to the sheath hub.The sidearm was not able to be pulled off with minimal force again.The sheath was inserted into the t-tube and pressurized to 200mmhg.The sheath and sidearm did not leak.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of sidearm separation is confirmed by visual inspection.The sidearm was returned detached from the valve body.The sideport and sidearm passed functional inspection after reconnection.The root cause of the separation is undetermined.
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Event Description
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It was reported that while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
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Search Alerts/Recalls
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