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Model Number 3241 |
Device Problems
Entrapment of Device (1212); Mechanical Problem (1384); Device Damaged by Another Device (2915)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
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Event Date 03/12/2019 |
Event Type
Injury
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Event Description
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It was reported that the burr became stuck in the lesion a rotalink plus 1.5mm selected for use in the distal right coronary artery (rca) after a rotawire extra support was placed in the lesion.The target lesion was approximately 20mmx3.0mm with mild tortuosity and severe calcification.The burr was unable to cross inside the pre-placed synergy stent from the stent proximal part, so it was advanced by dynaglide, and ablation was performed once.It started at 155000rpm, and decrease a maximum of 3000rpm.During the second ablation, it started at 150,000rpm and decrease to 120,000rpm, and then, the stall lamp was displayed.The burr became stuck in the distal rca.St elevation of the avf, 2 and 3 occurred along with a decrease in blood pressure.Another non-bsc guidewire was inserted.When the burr was pulled, it was released from being stuck.Visual inspection of the device once removed revealed that the pre-placed synergy stent was damaged and stuck to the shaft.Poba was performed by 2mm, and ivus checking was performed.Poba was again performed by 3.0, and non-bsc stent was placed in the rca distal.A synergy 3.5x38 was placed in the rca proximal.After that, poba was performed inside each stent.The procedure was completed without checking final ivus.The patient entered the ccu on that day without using assisted circulation.The patient's current condition is good.The physicians comment regarding the possible cause of the burr becoming stuck in the lesion was as follows.It was likely due that to the rotational burr interacted with the drug-eluting stent (des) that already placed in the lesion.It could also be a contributor that endosporium tissue was not yet sufficiently constructed as des was just placed about a month before this procedure.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.There was a damaged stent that was stuck on the coil that could not be removed.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil was stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to a melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that the burr became stuck in the lesion a rotalink plus 1.5mm selected for use in the distal right coronary artery (rca) after a rotawire extra support was placed in the lesion.The target lesion was approximately 20mmx3.0mm with mild tortuosity and severe calcification.The burr was unable to cross inside the pre-placed synergy stent from the stent proximal part, so it was advanced by dynaglide, and ablation was performed once.It started at 155000rpm, and decrease a maximum of 3000rpm.During the second ablation, it started at 150,000rpm and decrease to 120,000rpm, and then, the stall lamp was displayed.The burr became stuck in the distal rca.St elevation of the avf, 2 and 3 occurred along with a decrease in blood pressure.Another non-bsc guidewire was inserted.When the burr was pulled, it was released from being stuck.Visual inspection of the device once removed revealed that the pre-placed synergy stent was damaged and stuck to the shaft.Poba was performed by 2mm, and ivus checking was performed.Poba was again performed by 3.0, and non-bsc stent was placed in the rca distal.A synergy 3.5x38 was placed in the rca proximal.After that, poba was performed inside each stent.The procedure was completed without checking final ivus.The patient entered the ccu on that day without using assisted circulation.The patient's current condition is good.The physicians comment regarding the possible cause of the burr becoming stuck in the lesion was as follows.It was likely due that to the rotational burr interacted with the drug-eluting stent (des) that already placed in the lesion.It could also be a contributor that endosporium tissue was not yet sufficiently constructed as des was just placed about a month before this procedure.
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Search Alerts/Recalls
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