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 Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Event date: 2020.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, an instance of cord prolapse was observed after using a cook cervical ripening balloon w/stylet.No additional patient consequences were 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

Additional information was received 22feb2021: as reported, the device was being used pre-induction of labor.There was no malfunction of the device.The balloons were inflated 60 to 80 ml with sterile water.There is no information available on the date of event, lot number, or how long the device was in place.The patient had an emergency cesarean section (c-section).There was no harm to the patient other than cesarean delivery.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Event summary: as reported, an instance of cord prolapse was observed after using a cook cervical ripening balloon w/stylet.The device was being used pre-induction of labor.There was no malfunction of the device.The balloons were inflated 60 to 80 ml with sterile water.There is no information available on the date of event, lot number, or how long the device was in place.The patient had an emergency cesarean section (c-section).There was no harm to the patient other than cesarean delivery.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination was performed.As the product lot was not provided, reviews of complaint history and the device history record could not be conducted.There were no identified gaps in the quality control procedures.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The instructions for use provided with the device include prolapsed umbilical cord and ruptured membranes as contraindications for the device.The ifu also warns, "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 cesarean delivery." based on available evidence, cook has concluded that the cause of this event cannot be traced to the device.Cook will continue monitoring of similar complaints and have 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11293827
• MDR Text Key: 230747707
• Report Number: 1820334-2021-00274
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention