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 02/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported, the baby changed from head-first presentation to breech position after using the j-crbs.They were able to rotate the baby back to head-first presentation and the woman delivered vaginally.Additional details were provided.The fetal station at time of device insertion was determined by inner palpation and reported as above the pelvic inlet.The cook cervical ripening balloon w/stylet was placed before amniotomy with bishop score 4.The balloons were inflated to 80 + 80 ml with saline.The device was in place for 13 hours and no rupture of membranes occurred during placement.No induction medications were given to the patient.When the catheter was removed, the baby had rotated to breech presentation.Attempts to rotate the baby back to head-first presentation were successful.The induction was continued with angusta (misoprostol per os) and the baby delivered vaginally.In the doctor´s opinion there is nothing wrong with the device itself.The reason for the event is rather that the catheter shall not be used when the presenting part is too high or when the baby is in a non-stabilized position.Then the balloon mechanically can rotate the baby.No harm to the patient or baby has been reported.

Manufacturer Narrative

Investigation/evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.A review of the device history record could not be performed due to the user facility did not provide the lot number of the complaint device.A review of complaint history on the complaint device lot could not be performed because the lot number was not provided.The instructions for use (ifu) that accompanies this device provides the following information to the user related to the reported failure mode: contraindications: presenting part above the pelvic inlet.Warnings: the product should not be left indwelling for longer than 12 hours.Head-first presentation was verified with ultrasound on the same day as induction as well as palpatory before induction.At the time of device placement, fetal station during inner palpation was above the pelvic inlet.The product ifu indicates a contraindication of using the device when the presenting part is above the pelvic inlet.No difficulty was experienced when placing the j-crbs-184000.The j-crbs-184000 was in place for more than the product ifu indications of 12 hours.The device was in place for 13 hours.No malfunction of the device has been indicated.There are many reasons the baby may have moved after placement of the j-crbs-184000, to include mother¿s activity as well as possibility of polyhydramnios.The most probable cause of this event is using the j-crbs-184000 despite contraindication of presenting part above the pelvic inlet.A review of relevant manufacturing documents was conducted.It was concluded that the device in question was functionally inspected by quality control, and no notable gaps in production or processing controls were noted.The cook cervical ripening balloon with stylet is shipped with instructions for use (ifu), which clearly state the proper contraindications, warnings, precautions, and instructions for use with each device.The most likely cause of these events was the physician's failure to follow the contraindications and warnings stated in the ifu.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.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 new event information to report.

• 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: 8350272
• MDR Text Key: 136495633
• Report Number: 1820334-2019-00484
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR