(B)(6): A STUDY SITE REPORTED THAT A (B)(6) YEAR OLD FEMALE PRIMIGRAVIDA UNDERWENT LABOR INDUCTION WITH A CERVICAL RIPENING BALLOON (CRB) AND PITOCIN ON (B)(6) 2014. CRB WAS INSERTED ON (B)(6) 2014 AT 16:09 (VAGINAL BALLOON 30 ML OF SALINE, UTERINE BALLOON 60 ML OF SALINE). INSERTION OF CRB WAS CONSIDERED EASY. CRB FELL OUT AFTER ACHIEVING DESIRED CERVICAL DILATION AND WAS REMOVED (B)(6) 2014 AT 20:33. THE PT RECEIVED EPIDURAL ANESTHESIA ON (B)(6) 2014 BEGINNING AT 15:43. CHORIOAMNIONITIS SYMPTOMS OCCURRED ON (B)(6) 2014 (MATERNAL FEVER GREATER THAN 100.4 DEGREES F, SUSTAINED MATERNAL TACHYCARDIA, FETAL TACHYCARDIA). VACUUM ASSISTED VAGINAL DELIVERY OCCURRED ON (B)(6) 2014 AT 13:45. THE PT WAS TREATED WITH ANTIBIOTIC THERAPY. THIS EVENT WAS MARKED AS "POSSIBLY" RELATED TO THE CRB AND POSSIBLY RELATED TO THE INDUCTION PROCEDURE. IT WAS NOTED THAT THE EVENT DID NOT LEAD TO SERIOUS DETERIORATION IN HEALTH AND THE SITE RESPONDED THAT THE DEVICE DID NOT MALFUNCTION (B)(6) 2014.
N
Patient 1
EXPIRATION DATE IS UNK. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
N
Patient 1
NO COMPLAINT DEVICE WAS RETURNED FOR EVALUATION, HOWEVER, DURING INVESTIGATION, A REVIEW OF THE DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL (QC) WAS CONDUCTED. PER QUALITY CONTROL SPECIFICATION, THE DEVICE IS VERIFIED TO BE FREE OF EXCESS DEBRIS AND DISCOLORATION. THE DEVICE WAS TESTED FOR BIOCOMPATIBILITY PER ISO. THE INSTRUCTIONS FOR USE DOCUMENT (IFU) PROVIDED WITH THE DEVICE WARNS "PRODUCT SHOULD NOT BE LEFT INDWELLING FOR A PERIOD GREATER THAN 12 HOURS." THE IFU INSTRUCTS "CLEAN THE CERVIX WITH AN APPROPRIATE CLEANING SOLUTION TO PREPARE FOR DEVICE INSERTION" UNDER PATIENT PREPARATION THE IFU ALSO STATES THE INTENDED USE TO BE "THE COOK CERVICAL RIPENING BALLOON IS INDICATED FOR MECHANICAL DILATION OF THE CERVICAL CANAL PRIOR TO LABOR INDUCTION AT TERM, AND NEAR TERM, WHEN THE CERVIX IS UNFAVORABLE FOR INDUCTION. THE COOK CERVICAL RIPENING BALLOON MAY BE USED IN PATIENTS WITH INTACT OR RUPTURED MEMBRANES." THIS PRODUCT IS CURRENTLY IN A CLINICAL INVESTIGATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE REPORTED DIFFICULTY. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT (QERA), ADDITIONAL ACTIVITY IS NOT REQUIRED AT THIS TIME.