COOK, INC. COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure, additional (2564)
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Event Type
Injury
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Event Description
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According to the initial reporter, the event occurred approximately two months ago.A bakri balloon was placed for a postpartum hemorrhage.After being in place for 12 hours, necrosis was found.The pt had to have a hysterectomy performed.This pt had a bicornuate uterus prior to the placement of the device.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Manufacturer Narrative
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Evaluation: a review of the complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.Additionally, interview with personnel were conducted.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: the ifu states the contraindication of "untreated uterine anomaly" thus indicating that this patient with a bicornuate uterus was contraindicated for this device."the maximum inflation is 500 ml.Do not overinflate the balloon.Over-inflation of the balloon may result in the balloon being displaced into the vagina." "patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding." this patient had a uterus that was in the shape of a heart prior to the placement of the device." it is assumed that the user is referring to a bicornuate uterus.The device was contraindicated for this patient.The device was not designed to accommodate the shape of this patients uterus.Thus using this device could have caused excess pressure on the patients tissue leading to necrosis.Additionally, depending on the degree of the cleft or septation between the two uterine horns, this cleft could push against the bakri device resulting in excess pressure on the patients tissue leading to necrosis.While no images were provided, it is highly likely that the patient anatomy contributed to the necrosis as their condition was contraindicated for the use of this device.This ultimately led to the patient needing a hysterectomy.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided and the investigation the cause of this issue was most likely the patient condition and the end user not following label copy instructions.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.
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Event Description
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According to the initial reporter, the event occurred approximately two months ago.A bakri balloon was placed for a postpartum hemorrhage.After being in place for 12 hours, necrosis was found.The patient had to have a hysterectomy performed.This patient had a bicornuate uterus prior to the placement of the device.
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Search Alerts/Recalls
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