| Catalog Number J-SOS-100500 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Hemorrhage/Bleeding (1888); Rupture (2208)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Customer name and address= phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
|
| |
|
Event Description
|
|
As reported during a conference presentation (the 73rd annual congress of the (b)(6) society of obstetrics and gynecology), a (b)(6) year old (gravida 2 para 1) female underwent a total laparoscopic hysterectomy and developed a partial rupture of the right distal urinary duct after delivery of a stillborn fetus and use of a bakri tamponade balloon catheter.The stable pregnancy, which was the result of intracytoplasmic sperm injection (icsi), had been confirmed and no abnormalities were found upon screening, including ultrasound.At twenty-eight weeks and three days gestation, the patient presented with disappearance of fetal movement and was diagnosed with fetal death.Because the patient had previously delivered by caesarean section, the physician elected to deliver the stillborn baby by dilating the cervix with laminaria and inserting a cervical dilation balloon, followed by mechanical removal of the fetus.The fetus had not delivered after two days; therefore, the physician removed the cervical dilation balloon and started the administration of oxytocin under careful monitoring.The fetus was delivered; however, bleeding continued after the placenta was removed.The bakri tamponade balloon catheter was placed but repeatedly came out of the uterus.The physician then determined that the patient had placenta accreta.A total laparoscopic hysterectomy was performed and the uterus, weighing 1220 grams, was removed via the vagina.A partial rupture of the right distal urinary duct was confirmed after the uterus was removed and the vaginal incision was closed.An unspecified wj catheter/stent was inserted under cystoscope guidance and an end-to-end anastomosis was performed with the assistance of urology.The procedure lasted for one hour and fifty-six minutes.The patient was discharged from the hospital six days after the procedure and the stent was removed two months after the procedure.The patients outcome was reportedly favorable.After the procedure, placenta accreta, fetal premature coarctation of the ductus arteriosus, and stricture of the umbilical cord were diagnosed.It was also discovered that the patient had previously undergone a uteroscope-guided dilation and curettage for a missed abortion and removal of a fibroid, which was considered a possible cause for the placenta accreta.The full journal article is not available at this time.
|
| |
|
Manufacturer Narrative
|
|
Nerima general hospital informed cook on (b)(6) 2021 of an incident involving a bakri postpartum balloon (j-sos-100500) from and unknown production lot.As reported, a stable pregnancy had been confirmed with no abnormity discovered by nipi or ultrasound screening, but on 28 weeks + 3 days pregnancy, the patient came to the hospital for disappearance of fetal movement and was then diagnosed with fetal death.The physician attempted to deliver the stillborn baby after cervical dilation with laminaria by inserting a metreurysis (a single balloon for mechanical cervical dilation prior to labor induction) then pulling the stillborn baby mechanically.The stillborn baby could not be delivered even though the physician tried for two days, so he changed the delivery method to administration of oxytocin after removing the metreurysis under careful monitoring.The stillborn baby could be delivered successfully.However, bleeding after placental removal did not stop, so a bakri balloon was placed.The bakri repeatedly came out, so the physician judged it as placenta accreta, then performed total laparoscopic hysterectomy.36 minutes after total laparoscopic hysterectomy (tlh), the 1,220g of uterus was removed virginally.Partial rupture of the right distal urinary duct was confirmed after closing the edge of the cutting point of vagina, so a wj catheter/stent was inserted under cystoscope guidance and the end-to-end anastomosis was performed with the aid of urological section.Duration of the procedure was 1 hour 56 minutes.The patient was discharged from the hospital 6 days after the procedure.The placed stent was removed 2 months after the procedure, then the patient is having a favorable outcome.The full journal article is not available at this time.Investigation - evaluation reviews of the quality control procedures and instructions for use were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook has not received a complaint for a similar product and a similar failure mode in which the complaint product was returned for physical examination.A document-based investigation evaluation was performed.Cook could not complete a review of the device history record due to lack of lot information from the user facility.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.Review of the customer testimony and relevant manufacturing documents does not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The instructions for use provided with the device list contraindications for device use including, "arterial bleeding requiring surgical exploration or angiographic embolization," and, "cases indicating hysterectomy".The ifu also warns, ¿this device intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding." cook has concluded that the cause of the event cannot be traced to the complaint device.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
| |
|
Event Description
|
|
Additional information was received on (b)(6) 2021.The laminaria was in place for approximately 24 hours before delivery of the fetus.The physician attempted to place the bakri device three times.The balloon was inflated to approximately 100ml each time insertion was attempted.The device prolapsed immediately after insertion each time.The user was unable to pack the vaginal canal with iodine or antibiotic-soaked gauze due to the immediate expulsion of the device.Only one bakri balloon device was used.There was a reported collective blood loss of over 2 liters prior to and after the use of the device.There was no evidence of cervical rupture.Event is reported to have happened in 2021, however the exact date is unknown.
|
| |
|
Search Alerts/Recalls
|
|
