Device Problems
Kinked (1339); Difficult To Position (1467)
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Patient Problem
Vascular Dissection (3160)
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Event Date 02/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product investigation: the reported event of "a kink in the anatomy of the device" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.
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Event Description
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When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins.The puncture sites were pre-dilated with a 6f and 7f non-abbott products.A 12 f ultimum introducer was used on each side for the bilateral punctures.The patient's anatomy complicated access and dissections were caused on both sides.Ultrasound was used for femoral venous access.The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.
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Manufacturer Narrative
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Product evaluation: an event of dissection could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins.The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products.A 12 f ultimum introducer was used on each side for the bilateral punctures.The patient's anatomy complicated access and dissections were caused on both sides.Ultrasound was used for femoral venous access.The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.
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Event Description
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When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins.The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products.A 12 f ultimum introducer was used on each side for the bilateral punctures.The patient's anatomy complicated access and dissections were caused on both sides.Ultrasound was used for femoral venous access.The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.Please reference 3005334138-2018-00109 for other mdr.
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Search Alerts/Recalls
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