BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7213 |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); Vascular Dissection (3160); Foreign Body Embolism (4439)
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Event Date 05/16/2022 |
Event Type
Injury
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Event Description
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It was reported via facility medwatch report (b)(4) that shaft break, vessel dissection, and embolism occurred.A heart catheterization was performed in work up for a transcatheter aortic valve replacement (tavr).A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, when the balloon was backed out, the shaft of the balloon broke off "after the black tip, proximal part of the monorail" causing coronary artery dissection and embolization.Dissection was at 100% non-flowing and there was no snaring involved.The physician decided to leave the balloon in the vessel because the vessel was poor.The patient was monitored for 1.5 hours post procedure in the catheterization lab and then was moved to critical care for monitoring and overnight observation.An echocardiogram was performed to evaluate for left ejection friction and regional wall motion, no changes were noted.The patient was discharged the following day and will be anticipating tavr done in 1 month.
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Manufacturer Narrative
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E1: initial reporter title: risk manager.Device evaluated by mfr.: the complaint device was not received at the complaint investigation site for analysis.Photo media was provided for investigation review.Photos one and two show the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.The photo tree shows one part and the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.Photo four depicts a device that contains blood on the manifold and looks to be separated at the end of the shaft from the balloon.There also shows the lot number on the manifold 28906590 which matches the complaint batch, and therefore applies to this compliant.Photo five shows one part and the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.
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Event Description
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It was reported via facility medwatch report (b)(4) that shaft break, vessel dissection, and embolism occurred.A heart catheterization was performed in work up for a transcatheter aortic valve replacement (tavr).A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, when the balloon was backed out, the shaft of the balloon broke off "after the black tip, proximal part of the monorail" causing coronary artery dissection and embolization.Dissection was at 100% non-flowing and there was no snaring involved.The physician decided to leave the balloon in the vessel because the vessel was poor.The patient was monitored for 1.5 hours post procedure in the catheterization lab and then was moved to critical care for monitoring and overnight observation.An echocardiogram was performed to evaluate for left ejection friction and regional wall motion, no changes were noted.The patient was discharged the following day and will be anticipating tavr done in 1 month.
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Search Alerts/Recalls
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