It was reported that the guide wire was kinked when inserted into the body and it was broke when removed out from the body.Further, a resistance was observed during removing.Customer states that the broken guide wire caused to a blood vessel damage, and patient died during treatment.However, it is also stated that it is unknown if the exact reason of the death is caused by product or not.Customer states that complications from the cannulation procedure were the reason of the damage to patients health, and therefore there was no direct relationship between the broken guidewire and the patient's death.Complaint #: (b)(4).
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