Catalog Number IAB-06840-U |
Device Problem
Leak/Splash (1354)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 04/30/2016 |
Event Type
Injury
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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 the rn in the cath lab was calling to troubleshoot frequent possible helium loss alarms.The intra-aortic balloon (iab) was just inserted in the cath lab without difficulty in the right femoral artery.Per the rn, "the iab looks good under fluoroscopy." the patient is bradycardic at 46bpm, no noted kinks.The clinical support specialist (css) discussed reasons for possible helium loss alarms.During our discussion we attempted to pump at 36cc volume, but the alarm occurred again.The rn sent the css a copy of the current strip alarm and no significant kinking noted.The css walked the rn through a leak test and for several minutes only a high pressure alarm was noted with no drop in bpw (balloon pressure waveform) baseline pressure.The css explained that this likely meant that there was an abrasion in the iab and removal was recommended.The css spoke with the rn several times via phone and text.The iab was removed without difficulty and another iab was inserted into the opposite groin (left femoral) without difficulty.The rn reported minimal delay in therapy and no complications with the patient.At last communication, the pump was pumping with the new iab at full volume with no alarms, appropriate bpp and sizing and achieving the goals of therapy.
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Manufacturer Narrative
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(b)(4).The sample was returned in a sealed biohazard bag.The iab bladder membrane was unwrapped and fully covering the iab distal tip.This may indicate the bladder is damaged.The teflon sheath was approximately 11.4cm from the covered iab distal tip.Buckling of the sheath was noted starting at approximately 15.0cm to 26.2cm from the covered iab distal tip.Some fluid/blood was noted inside the sheath sidearm.The iab hemostasis cuff was connected to the cathgard.The one-way valve was connected and tethered to the short driveline tubing.Blood was noted on the exterior of the bifurcate, sheath, bladder, cathgard and on the interior of the bladder.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." other remarks: the bladder thickness was measured at six points with measurements ranging within specification.Upon further investigation, the bladder was confirmed to not be attached to the iab distal tip.No other damage was noted to the bladder.Engineering has been notified; nc60035184 has been initiated to investigate the cause of this issue.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The device was unable to be leaked tested due to the damaged state of the device.A lab inventory 0.025in guidewire was front loaded through the iab luer.The guidewire was able to advance through the central lumen while excreting blood through the distal tip before exiting.Blood exited with the guidewire.The guidewire was back loaded through iab distal tip.The guidewire was able to advance through the central lumen.Blood exited with the guidewire.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A device history record (dhr) 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 leak (suspected) is confirmed.Upon visual inspection, the bladder was not attached to the iab distal tip.Engineering has been notified.Nc60035184 has been initiated to investigate cause of the issue.
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Event Description
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It was reported that the rn in the cath lab was calling to troubleshoot frequent possible helium loss alarms.The intra-aortic balloon (iab) was just inserted in the cath lab without difficulty in the right femoral artery.Per the rn, "the iab looks good under fluoroscopy." the patient is bradycardic at (b)(6)bpm, no noted kinks.The clinical support specialist (css) discussed reasons for possible helium loss alarms.During our discussion we attempted to pump at 36cc volume, but the alarm occurred again.The rn sent the css a copy of the current strip alarm and no significant kinking noted.The css walked the rn through a leak test and for several minutes only a high pressure alarm was noted with no drop in bpw (balloon pressure waveform) baseline pressure.The css explained that this likely meant that there was an abrasion in the iab and removal was recommended.The css spoke with the rn several times via phone and text.The iab was removed without difficulty and another iab was inserted into the opposite groin (left femoral) without difficulty.The rn reported minimal delay in therapy and no complications with the patient.At last communication, the pump was pumping with the new iab at full volume with no alarms, appropriate bpp and sizing and achieving the goals of therapy.
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Manufacturer Narrative
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Qn#(b)(4).An additional investigation was performed with engineering.The iab was submerged in water, with the bladder distal tip and iab distal tip blocked off, and leak tested.The sample failed leak testing and numerous leaks were found on the outer lumen.The leaks on the outer lumen are confirmed at approximately 38.0cm, 39.4cm, 40.5cm, 44.0cm and 73.7cm from the iab distal tip.Conclusion: based on the reported complaint we initially considered this issue to be related to nc60035184, however, further investigation determined that the reported complaint is unrelated to nc60035184.Other remarks: based on our analysis, the reported complaint of a suspected leak is confirmed.Numerous leaks on the outer lumen could have potentially caused the reported helium loss alarms.Due to the condition of the returned iab it is not possible to determine when or how the bladder detached from the tip.The catheter body was severely damaged upon return.There were several leaks in the outer lumen, and the loose condition of the bladder is an indicator that the catheter body was stretched.A stretched catheter body also indicates that at some point the catheter was pulled with excessive force.The bladder damage may have been a result of attempting to remove the catheter through the sheath.The root cause of the outer lumen leaks is undetermined.
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Event Description
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It was reported that the rn in the cath lab was calling to troubleshoot frequent possible helium loss alarms.The intra-aortic balloon (iab) was just inserted in the cath lab without difficulty in the right femoral artery.Per the rn, "the iab looks good under fluoroscopy." the patient is bradycardic at 46bpm, no noted kinks.The clinical support specialist (css) discussed reasons for possible helium loss alarms.During our discussion we attempted to pump at 36cc volume, but the alarm occurred again.The rn sent the css a copy of the current strip alarm and no significant kinking noted.The css walked the rn through a leak test and for several minutes only a high pressure alarm was noted with no drop in bpw (balloon pressure waveform) baseline pressure.The css explained that this likely meant that there was an abrasion in the iab and removal was recommended.The css spoke with the rn several times via phone and text.The iab was removed without difficulty and another iab was inserted into the opposite groin (left femoral) without difficulty.The rn reported minimal delay in therapy and no complications with the patient.At last communication, the pump was pumping with the new iab at full volume with no alarms, appropriate bpp and sizing and achieving the goals of therapy.
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Search Alerts/Recalls
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