| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-20 | 0 | 1. R |
Patient 1
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. COMMON DEVICE NAME: CATHETER, BALLOON, DILATION OF CERVICAL CANAL. LOT #: LOT NUMBER 7783756 OR 8179355 TO BE CONFIRMED. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
Patient 1
IT WAS REPORTED THAT A DOCTOR HAD HEARD THAT TWO OR THREE BABIES HAD CHANGED POSITION IN THE UTERUS AFTER A J-CRBS-184000 HAD BEEN USED. THE DOCTOR DIDN?T HAVE MUCH MORE INFORMATION THAN THIS. AS REPORTED AFTER FURTHER FOLLOW UP, THE HOSPITAL HAS HAD TWO CASES WHERE THE BABY?S HEAD CHANGED POSITION AFTER USING THE J-CRBS. THE FIRST CASE IS REPORTED IN MFR. REPORT # 1820334-2018-02776 AND SECOND CASE IN THIS MFR. REPORT. "THE SECOND CASE WAS A NULLIPAROUS WOMAN WHERE THE BABY CHANGED TO BREECH POSITION AFTER INSERTING J-CRBS. THEY WERE NOT ABLE TO CHANGE IT BACK TO THE RIGHT POSITION AND THEY HAD TO PERFORM A C-SECTION." ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE COOK CERVICAL RIPENING BALLOON WITH ADJUSTABLE STYLET CONTAINS THE FOLLOWING CONTRAINDICATIONS, WARNINGS, AND POTENTIAL ADVERSE EVENTS: CONTRAINDICATIONS: PATIENT RECEIVING OR PLANNING TO UNDERGO EXOGENOUS PROSTAGLANDIN ADMINISTRATION; PLACENTA PREVIA, VASA PREVIA, OR PLACENTA PERCRETA; TRANSVERSE FETAL ORIENTATION; PROLAPSED UMBILICAL CORD; PRIOR HYSTEROTOMY, CLASSIC UTERINE INCISION, MYOMECTOMY OR ANY FULL-THICKNESS UTERINE INCISION; PELVIC STRUCTURAL ABNORMALITY; ACTIVE GENITAL HERPES INFECTION; INVASIVE CERVICAL CANCER; ABNORMAL FETAL HEART-RATE PATTERNS; BREECH PRESENTATION; MATERNAL HEART DISEASE; MULTIPLE GESTATIONAL PREGNANCY; POLYHYDRAMNIOS; PRESENTING PART ABOVE THE PELVIC INLET; SEVERE MATERNAL HYPERTENSION; ANY CONTRAINDICATION TO LABOR INDUCTION; RUPTURED MEMBRANES. WARNINGS: CONCOMITANT USE OF THE COOK CERVICAL RIPENING BALLOON WITH EXOGENOUS PROSTAGLANDINS MAY INCREASE THE RISK OF ADVERSE EVENTS ASSOCIATED WITH PROSTAGLANDIN ADMINISTRATION, INCLUDING, BUT NOT LIMITED TO: UTERINE HYPERSTIMULATION, IMPAIRED UTERO-PLACENTAL CIRCULATION, TACHYSYSTOLE, UTERINE RUPTURE, PLACENTAL ABRUPTION, AMNIOTIC FLUID EMBOLISM, PELVIC PAIN, RETAINED PLACENTA, SEVERE GENITAL BLEEDING, SHOCK, FETAL BRADYCARDIA, FETAL DEATH, AND MATERNAL DEATH. 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 UTERINE 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. THE SAFETY AND EFFECTIVENESS OF THE COOK CERVICAL RIPENING BALLOON HAS NOT BEEN ESTABLISHED AMONG WOMEN WITH AN OBSTETRICAL HISTORY OF LOW TRANSVERSE CESAREAN SECTION. THE SAFETY AND EFFECTIVENESS OF EXTRA-AMNIOTIC SALINE INFUSION WITH THE COOK CERVICAL RIPENING BALLOON HAS NOT BEEN ESTABLISHED. ALWAYS INFLATE THE BALLOON WITH A STERILE SALINE. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. IF SPONTANEOUS RUPTURE OF MEMBRANES OCCURS WHILE THE COOK CERVICAL RIPENING BALLOON IS IN PLACE, THERE IS A RISK THAT THE UTERINE BALLOON COULD BECOME ENTANGLED IN THE UMBILICAL CORD, NECESSITATING EMERGENT CAESAREAN DELIVERY. POTENTIAL ADVERSE EVENTS: RISKS ASSOCIATED WITH USE OF THE COOK CERVICAL RIPENING BALLOON AND LABOR INDUCTION MAY INCLUDE, BUT ARE NOT LIMITED TO: PLACENTAL ABRUPTION; UTERINE RUPTURE; SPONTANEOUS RUPTURE OF MEMBRANES; SPONTANEOUS ONSET OF LABOR; DEVICE EXPULSION; DEVICE ENTRAPMENT AND/OR FRAGMENTATION; MATERNAL DISCOMFORT DURING AND AFTER INSERTION; FAILED DILATION OR NEED FOR CAESAREAN DELIVERY; CERVICAL LACERATION; BLEEDING; RISK OF PRE-TERM LABOR AND BIRTH IN SUBSEQUENT PREGNANCY.