Model Number 29710 |
Device Problems
Entrapment of Device (1212); Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 08/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Weight: (b)(6) kg.
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Event Description
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It was reported that the rotawire was separated and remained inside patient.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5 mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0 x 210 mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5 x 20 mm non bsc balloon catheter was used.The 1.5 mm burr was then exchanged to a 1.25 mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.
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Manufacturer Narrative
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Weight: 47.3kg.Device evaluated by manufacturer: the device was returned for analysis.The guidewire had the spring tip detached; the spring tip was returned inside of a petri dish.The spring tip was kinked and stretched.The core wire was fractured and at the end of the fractured section, marks of rotational wear were found; the affected area was located approximately at 230.7 cm from the proximal end.The other section of the guidewire was not returned.No more damages were found in the device.Dimensional inspection of the outer diameter (od) of middle and od of the proximal section of the device were performed and were within specification.Dimensional inspection of the overall length and od of the distal tip of the device could not be performed due to device condition.A review of the pictures captured by the customer, showing the damages of the device, was performed and they matched with the damages found during the product analysis; the images showed the spring tip detached, kinked and stretched; besides, the length of the guidewire appeared shorter than normal and some rotational wear marks were observed.No more damages/abnormalities were observed.
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Event Description
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It was reported that the rotawire was separated and remained inside patient.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0x210mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5x20mm non bsc balloon catheter was used.The 1.5mm burr was then exchanged to a 1.25mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.It was further reported that the device was pulled out from the patient's body and there were no visible issue/damaged noted on the burr.The patient was stable after the procedure.
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Event Description
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It was reported that the rotawire was separated and remained inside patient.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0x210mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5x20mm non bsc balloon catheter was used.The 1.5mm burr was then exchanged to a 1.25mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.It was further reported that the device was pulled out from the patient's body and there were no visible issue/damaged noted on the burr.The patient was stable after the procedure.
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Manufacturer Narrative
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A4.Weight: 47.3kg.
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Search Alerts/Recalls
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