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 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: week of (b)(6) 2020.(b)(6).(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 around an unspecified procedure using a cook cervical ripening balloon w/stylet, a cord presentation occurred.The outcome was favorable.The exact sequence of events is unknown.No alleged product malfunction was reported.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Event Description

Additional information was received on 05mar2020: provided details and sequence of events as follows: (b)(6) 2020 at 21:21 the cook cervical ripening balloon w/stylet (crb) was placed.(b)(6) 2020 at 03:35 spontaneous rupture of membranes (srom), the crb was removed from the patient, the cord prolapse was noted, and the patient was immediately moved to the operating room.04:03 an emergency cesarean section was performed.No additional adverse events have been reported.

Manufacturer Narrative

Additional information: e3: occupation: maternity ward manager.Investigation - evaluation: it was reported, a cook cervical ripening balloon w/stylet (crb) was used to induce a patient prior to delivery.After 4 hours and ten minutes indwelling, spontaneous rupture of membranes occurred and cord prolapse was noted.The patient was transferred immediately for an emergency cesarean procedure.No device malfunction was reported.A document-based investigation was performed including a review of trends, 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 manufactured out of specification.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the complainant.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the complainant.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: contraindications: prolapsed umbilical cord, pelvic structural abnormality, ruptured membranes instructions for use: note: the device is not intended to be in place for longer than 12 hours.Time the placement of the device 12 hours prior to the planned induction.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 don¿t know any details regarding the pregnancy history or any other specific risk factors this mother may have had for umbilical cord prolapse.The most likely factor to have contributed to this event includes is the fetal position/station/lie at the time of the spontaneous 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.It is not likely that a manufacturing issue contributed to this event as there is no allegation that the product malfunction in any way.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.Based on the available information, it was concluded that the cause of this incident cannot be traced to the complaint device.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: 9700159
• MDR Text Key: 190557688
• Report Number: 1820334-2020-00334
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR