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 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be submitted should additional relevant information become available.

Event Description

According to the patient, she was administered a cook cervical ripening balloon to mechanically induce labor.The balloon was in place for four hours and during this time she was unable to urinate.She stated that after straining tremendously for a bowel movement, a small amount of urine was released, but not significant enough to relieve the pain and pressure she felt.The straining from that attempt to release her urine led to tremendous pelvic issues, with pubic bones mis-aligning, there was no other pushing happening except for when the cook balloon was blocking her urethra.As reported, the cervical ripening balloon was removed and pitocin was then administered, but it also failed to induce labor.Due to both the balloon being removed early and pitocin failing to induce labor, the patient was sent for a c-section.It was reported that the usage of the cook cervical ripening balloon caused the patient to misalign her pelvic bones and that it failed to induce labor, so the patient required a c-section.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

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable investigation - evaluation reviews of the instructions for use (ifu) and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device is shipped with instruction for use (ifu) which notes: contraindications: "pelvic structural abnormality" warnings: "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." potential adverse events: "maternal discomfort during and after insertion" cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a trackwise search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.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 where the complaint product was returned for physical examination.Clinical assessment notes that depending upon the anatomical location of the patient¿s urethra, it is possible that the inflated crb balloon could obstruct the outflow of urine.It is not likely however that the patient could strain enough to misalign her pelvic bones.Due to the fact that the patient received pitocin, and this did not lead to a vaginal delivery either, the most likely cause of her failed induction was cephalopelvic disproportion (the baby was too big to fit through the pelvic inlet/canal).At this time, the most likely contributing factor of this event is patient anatomy related.Cook has concluded that a definitive cause of the event could not be traced to the device.We will continue our 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.

• 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: 8956186
• MDR Text Key: 156313496
• Report Number: 1820334-2019-02171
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• 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: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other