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 Uterine Perforation (2121)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

Customer name and address= postal code: (b)(6); phone: (b)(6) this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, a cook cervical ripening balloon w/stylet was used during a vbac (vaginal birth after cesarean), and the patient's uterus ruptured.The uterus was repaired.Additional information has been requested.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a cook cervical balloon with stylet from an unknown production lot.As reported, the device was used on patient with a bmi of 50 who had various failed iol methods at 37 weeks.This was the fifth pregnancy with the previous four being vaginal deliveries.The operator believed the head was fixed, but due to bmi it was difficult to be certain.On removal, the baby had turned and was in an unstable oblique lie.A cesarean was performed, and the baby was successfully delivered.No adverse effects were 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 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.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: intended use: "the cook cervical ripening balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction." contraindications: "transverse fetal orientation" "breech presentation" "any contraindication to labor induction" potential adverse events: "failed dilation or need for caesarean delivery" a clinical assessment was completed and noted: additional information received on 23sep2021 indicating that the patient did not have a uterine rupture.Additional information regarding the patient was provided.The patient was reported to have had a bmi of 50 (morbid obesity), underwent various failed induction-of-labor (iol) attempts at or around 37 weeks gestation, this was the patient¿s 5th pregnancy with a history of 4 vaginal deliveries.Factors such as obesity, attempted and failed iol¿s, and multiparity/grand multiparity (a patient who has had more than 2 deliveries) increase chances of cesarean section, uterine rupture, and/or other complications associated with pregnancy, labor, and delivery.Additionally, due to the elevated bmi, it was difficult for the provider to determine in the fetus maintained a fixed, downward, head position.Upon removal of the device, it was noted that the fetus was in an unstable oblique lie (horizontal in the uterus) position, thus a caesarean section would be indicated.However, per the ifu, the additional information provided would indicate that the use of this device would be contraindicated in this patient.Based on the information provided for this clinical assessment, the most probable cause of this event is related to user/procedural issues related to patient factors/history.With the partial information available at this time, specifications regarding additional patient factors are limited.Based on the information provided, the event can likely be traced to the off-label use of the device for a contraindication in our instructions for use (ifu).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.

Event Description

Additional information received 23sep2021 indicating that the patient did not have a uterine rupture as initially reported.Additional information regarding the patient was provided.The patient was reported to have had a bmi of 50 (morbid obesity), underwent various failed induction-of-labor (iol) attempts at or around 37 weeks gestation, this was the patient¿s 5th pregnancy with a history of 4 vaginal deliveries.They believed the head was fixed but due to bmi it was difficult to be certain.On removal the baby had turned and was in unstable oblique lie and they performed c/s.Mother and baby fine.No further action taken.

• 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: 12309800
• MDR Text Key: 266104861
• Report Number: 1820334-2021-01962
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention