Catalog Number M0035425100 |
Device Problem
Premature Activation (1484)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
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Event Date 02/16/2017 |
Event Type
Injury
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Event Description
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The physician experienced friction while trying to repositioned the coil.It was reported that the coil was repositioned approximately 3 to 4 times when it detached.The physician proceeded to cut the hub of the microcatheter in attempt to remove the coil; however, the coil became jammed in the microcatheter; therefore, the physician removed the microcatheter along with the coil.There was a surgical delay, and the patient's blood pressure dropped several times and the patient lost one liter of blood.It was reported that there was no residual effect on the patient due to this event.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the main coil was physically broken off the delivery wire below the main junction, and the coil suture was broken.In addition, the delivery wire was kinked/bent likely due to handling.Blood residue was noted on the returned coil which could indicate insufficient flush; this however cannot be conclusively determined because it was indicated that flush was used during procedure.The break observed at the main junction was likely due to excessive force used reposition of the device limiting its performance during use.Therefore, it was determined that the reported event was related to operational context.The patient hemorrhage is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu) and anticipated in nature.
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Event Description
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The physician experienced friction while trying to reposition the coil.It was reported that the coil was repositioned approximately 3 to 4 times when it detached.The physician proceeded to cut the hub of the microcatheter in attempt to remove the coil; however, the coil became jammed in the microcatheter; therefore, the physician removed the microcatheter along with the coil.There was a surgical delay, and the patient's blood pressure dropped several times and the patient lost one liter of blood.It was reported that there was no residual effect on the patient due to this event.
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Search Alerts/Recalls
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