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Cook has received two medwatch reports regarding this case.One report submitted by a voluntary reporter who knew the patient personally (mw5087294); and a second report submitted by the user facility (mw5087736) where the incident occurred.The report containing patient identifier (b)(6) references adverse events and the patient death involving the infant, and the report containing patient identifier (b)(6) references the adverse events surrounding the mother.Additional information has been requested and provided by the user facility.As reported by the user facility, during labor induction using a cook cervical ripening balloon w/stylet, the patient experienced chorioamnionitis, severe pre-eclampsia, cephalopelvic disproportion, and fetal tachycardia.Subsequently, the patient¿s infant experienced fetal sepsis of the newborn due to escherichia coli (e.Coli), newborn respiratory syndrome, thick meconium stained amniotic fluid, persistent pulmonary hypertension in newborn (pphn), metabolic acidosis, disseminated intravascular coagulation (dic), and thrombocytopenia resulting in fetal death.Patient (b)(6) was admitted (b)(6) 2019 1300.Presentation at admission was normal with normal labs and urinalysis and both heart rates (mother and infant) within normal limits per the voluntary reporter.Per the user facility admission b/p was 132/92, maternal heart rate was 74, temp was 98.0 f orally.Labs completed on admission included a cbc (all within normal reference range), type and screen (a+ and negative screen), uric acid (normal within reference range) , urine protein/creatinine ratio (high at 0.69 and consistent with a diagnosis of pregnancy induced hypertension (pih)/pre-eclampsia) , and comprehensive metabolic profile (all within normal reference range except c02 which was 20 (low), blood glucose which was 112 (high), and alkaline phosphatase which was high at 219.Fetal heart rate tracing was noted multiple times on (b)(6) 2019 and (b)(6) 2019 to have moderate variability, accelerations present, and decelerations absent.Fetal and maternal tachycardia were noted after the mother developed fever prior to c-section delivery.Patient (b)(6) was a prima gravida (first pregnancy) of advanced maternal age at 40+1 weeks gestation and had conceived via ¿a procedure to impregnate¿ according to the voluntary reporter.Comorbidities confirmed by the user facility include advanced maternal age (ama) and pregnancy induced hypertension (pih), and these were the reported medical indications for labor induction.Timeline of events as follows: (b)(6) 2019.13:00-per the user facility, there is no documentation in the medical record indicating if or how the cervix was prepared or cleansed prior to attempted placement of a j-crbs-184000.This was the first attempt to place the j-crbs-184000 and was unsuccessful as documented in the medical record, "(b)(6) 2019 @1300 cook catheter placement attempted without success." according to the voluntary reporter, this physician made several attempts (exact number of attempts unknown) and was unsuccessful.Buccal cytotec (prostaglandin) was ordered.15:22 ¿ cytotec po given.No dosage information was provided.17:20 ¿ cytotec po given.No dosage information was provided.21:20 ¿ per the user facility, a j-crbs-184000 device was successfully placed under direct visualization without difficulty.Although requested, there is no documentation in the medical record indicating if, or how, the cervix was prepared or cleansed prior to placement of the j-crbs-184000.It is unknown if this was the same device as the first attempt, or a second device.This information was requested from the user facility.The user facility informed cook that normal practice would be to discard the first device and open a second device for a repeat attempt.It is unknown if a new, sterile device was used for each attempt.The user facility also stated there is no documentation in the medical record regarding the number of attempts.There was no documentation in the medical record regarding how the cervix was prepped prior to insertion.There was no documentation in the medical record regarding at what point the stylet was removed, or whether there was any distance between the hub of the stylet and the proximal end of the balloon catheter.There was no evidence in the medical record that the stylet was bent at any time during use.Each balloon was inflated with 80 ml.There was no documentation of device failure in the medical record.The hospital is unable to provide the product lot number, and the device is not available for return.The fetal position at the time of crb placement was vertex and -3 station.No bishop score was documented.Per the user facility, vital signs and vaginal exams were monitored via routine labor management and fetal heart rate was continuously monitored per routine labor management.No additional information was provided regarding specific treatments or interventions that were administered, however it was noted that no fetal scalp electrode (fse) was used.22:55 ¿ spontaneous rupture of membranes (srom) occurred.Amniotic fluid was found to be meconium stained.The j-crbs-184000 remained in place after srom occurred.(b)(6) 2019.04:17 ¿ cytotec po given.No dosage information was provided.06:17 ¿ cytotec po given.No dosage information was provided.09:38 ¿ j-crbs-184000 removed, indwelling 12hours 18minutes.15:34 ¿ per the voluntary reporter, two hours after the crb was removed, patient (b)(6) began to vomit, proceeded into rigors, and spiked a temperature of 103degrees fahrenheit.The staff did not recognize sepsis and treated eclampsia and given a large dose of magnesium to slow the rigors so she could have an emergency c-section.Per the user facility, the patient (b)(6) developed a fever of 100.9 degrees on (b)(6) 2019 at 1534 (5 hours and 56 minutes after crb removal and 16 hours and 39 minutes after srom) 15:43 ¿ per the user facility, magnesium sulfate started in accordance with order pathway for the indication of seizure prophylaxis and severe pih.16:17 ¿ per the user facility, antibiotics started.Medication and dosage were requested but not provided to cook.17:37 ¿ cesarean section started.17:44 ¿ cesarean section completed.Per the voluntary reporter, at the time of delivery, the infant male, patient (b)(6), was limp and lifeless with a pulse and respirations.The baby had a small wound on his forehead.Per the user facility: apgar scores: 3, 7, and 8 (at one, five, and 10 minutes).Venous cord gas at delivery, 7.11 (acidotic).Nicu nurse assessment noted a small red mark between the eyes on the forehead.The cause of this mark was not documented in the medical record.As reported by the user facility, the infant, patient (b)(6) died on (b)(6) 2019.In addition to the chronological series of events the user facility provided the following relevant information: a pathology study of the placenta was completed.Findings include: acute chorioamnionitis.Three vessel cord with funisitis.Mature 3rd trimester placenta with sparse perivillous and subchorionic fibrin deposits.Disrupted maternal surface; completeness of cotyledons cannot be confirmed grossly.A discharge summary for the infant, patient (b)(6), was provided from the user facility.The discharge summary included final diagnoses: sepsis of newborn.Newborn respiratory distress syndrome.Thick meconium stained amniotic fluid.Pphn (persistent pulmonary hypertension in newborn).Sepsis of newborn due to escherichia coli.Disseminated intravascular coagulation in newborn.Acidosis, metabolic.Thrombocytopenia.As reported by the user facility, there is no documentation in the medical record to indicate if the device caused or contributed to the reported events.As stated by the voluntary reporter: ¿there have been three women who have come forward here in the hospital to say that they have had this balloon placement, and all reported that their labor became complicated and they had to have emergency c-sections.¿ per the user facility: ¿not aware of any women with complications as described¿.
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Investigation ¿ evaluation.A visual inspection of the complaint device could not be performed as the device was not returned.A document based investigation was performed including a review of instructions for use (ifu), review of specifications, and quality control data.A review of the device history record (dhr) could not be completed due to lack of lot information from the user facility.A search of other complaints associated with the complaint device lot number could not be completed due to lack of lot information from the user facility.The ifu provides the following information to the user related to the reported clinical situation: warnings: the stylet should only be used to traverse the tip of the catheter through the cervix and should be removed as soon as the uterine balloon is above the level of the internal iterance opening (internal os) prior to full insertion of the catheter.Aggressive insertion may result in injury to the baby.The product should not be left indwelling for longer than 12 hours.Contraindication: patient receiving or planning to undergo exogenous prostaglandin administration.Ruptured membranes.Instructions for use: clean the cervix with an appropriate cleaning solution to prepare for device insertion.Using the moldable stylet use the cervical ripening balloon with stylet to traverse the cervix if necessary.Note: once the cervix has been traversed and the uterine balloon is above the level of the internal uterine opening (internal os) remove the stylet before further advancing the catheter.Based upon investigation performed, cook has concluded incorrect use of the device could have potentially contributed to the event.The ifu contraindicates concomitant use with prostaglandins, presenting part above the pelvic inlet, and leaving the j-crbs-184000 in place for over 12 hours, even after spontaneous rupture of membranes.Once the device is introduced into the vagina and cervical os, it is no longer sterile and may be contaminated with any pathogens that are present on the tissue it touches.If membranes are no longer present to provide a sterile barrier to the infant and the mother, the risk of infection is greatly increased.Cook has concluded a sequence of events occurred, not related to device failure, resulting in sepsis of the infant leading to death.There is no evidence of product malfunction documented in the sequence of events or from complaint investigation findings.The investigation determined that off label use of the device potentially contributed to the reported event.The risk analysis for this situation was reviewed, and it was determined that no additional risk mitigating activity is required at this time.Cook will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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