MAUDE Adverse Event Report: COOK INC COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Catalog Number J-CRBS-184000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: maternity ward manager.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported, after induction of labor for reduced fetal movement, using a cook cervical ripening balloon w/stylet (crb), an umbilical cord prolapse occurred.Provided details and sequence of events as follows: on (b)(6) at 18:15 the crb was placed.19:48 the crb was removed due to bleeding (source of bleeding not specified), cervix dilated 1 cm.On (b)(6) at 01:21, epidural sited.02:40 artificial rupture of membranes (arm) was performed, cervix dilated 1cm.05:34 cervix dilated 2cm, draining blood stained liquor, cardiotocography (ctg) normal.09:30 fetal bradycardia noted during vaginal exam (ve), cervix dilated 2cm, cord prolapse noted, mother was transferred to the operating room.09.49 a category 1 cesarean section was done.Baby delivered in good condition.No additional consequences to the patient have been reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Cook was informed on 05mar2020 of an incident involving a cook cervical balloon with stylet (j-crbs-184000) from an unknown production lot.As reported, on (b)(6) 2020 the complaint device was used to induce a patient prior to delivery.After 1 hour and 33 minutes, the balloon was removed due to bleeding.5 hours and 33 minutes later, an epidural was sited.1 hour and 19 minutes later artificial rupture of membranes (arm) was performed, and the cervix was 1 cm dilated.6 hours and 50 minutes late the cervix was 2cm dilated.3 hours and 56 minutes later, fetal bradycardia was noted and cord prolapse was noted.The patient was transferred and underwent a cesarean delivery.The baby was delivered in good condition.No malfunction of the complaint device was reported.Investigation - evaluation: a document-based investigation was performed including a review of instructions for use (ifu) and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.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 review of the device history record could not be completed due to lack of lot information from the user facility.A review of the complaint history could not be completed due to lack of information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: contraindications: "prolapsed umbilical cord", "presenting part above the pelvic inlet", "ruptured membranes" it should be noted that umbilical cord prolapse is a known risk factor inherent with vaginal deliveries.There are many factors that contribute to this risk including parity, amniotic fluid volume variances, prematurity, fetal station, umbilical cord length, etc.The occurrence rate of umbilical cord prolapse with vaginal deliveries worldwide is approximately 0.6% not considering of any methods for labor induction.In this case, we know that the patient did undergo artificial rupture of membranes (arm), and this is known to increase risk of umbilical cord prolapse.Based on the limited information provided it is difficult to conclude any definitive causes for these reported events.The most likely factor to have contributed to the cord prolapse includes the fetal position/station/lie at the time of membrane rupture.It is likely that the presenting part was not fully engaged in the pelvic inlet at the time of rupture, allowing the umbilical cord to slip in front of the baby.The most likely cause of the bleeding reported early in the labor process was normal bleeding related to dilation/stretching of the cervix.Later in the labor process when it was reported that the amniotic was blood stained, this was likely related to some degree of premature placental detachment.It is not likely that a manufacturing issue contributed to this event as there is no allegation that the product malfunction in any way.Based on the available information, it was concluded that the cause of the event cannot be traced to the complaint device and the reported adverse event was most likely related to the patient condition.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9834404
• MDR Text Key: 193277826
• Report Number: 1820334-2020-00610
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR