MAUDE Adverse Event Report: COOK, INC. COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bleeding (1738); No Code Available (3191)

Event Date 06/25/2015

Event Type  Injury  

Event Description

During a labor induction procedure, a patient with placenta previa commenced bleeding with ablation of placenta after introducing the cook cervical ripening balloon w/stylet.The physician reports that mother and child are now healthy.At present no knowledge or report about further patients details were made available.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects after this occurence.

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Manufacturer Narrative

(b)(4).******investigation****** a review of the complaint history, instructions for use (ifu) and quality control (qc) was conducted for the purpose of this investigation.Product was not returned to assist with the investigation.Per qc specification, the balloon catheter is inspected and tested for proper effectiveness.The ifu lists the appropriate intended use, contraindications, warnings and precautions, potential adverse events, and proper usage instructions.Per the description of event, the patient has placenta previa, which is listed as a contraindication in the ifu.The ifu states under potential adverse events, "risks associated with use of the cook cervical ripeneing balloon and labor induction may include, but are not limited to: placental abruption.Failed dilation or need for caesarean delivery.Cervical laceration.Bleeding.Risk of pre-term labor and birth in subsequent pregnancy." under the instructions for use section the ifu lists, "patient preparation.1.Perform an abdominal ultrasound to confirm singleton, vertex presentation and to rule out partial or complete placenta previa and/or placenta percreta." the description of event stated that the patient had an obvious placenta previa.This condition is contraindicated in the ifu, and is listed in the patient preparation step of the ifu to check for placenta previa.It is unknown whether this condition was discovered on imaging prior to the use of the crbs balloon, or was discovered after following the complications that were noted during the case.Additional information provided stated that after the device was placed, the patient had immediate bleeding and abruption of the placenta.It is likely that the use of the device in a patient with placenta previa (a condition contraindicated for this device) contributed to the complications during labor.The baby was delivered via a cesarean section.We have notified appropriate personnel and will continue to monitor for similar complaints.

Event Description

During a labor induction procedure, a patient with placenta previa commenced bleeding with ablation of placenta after introducing the cook cervical ripening balloon w/stylet.The physician reports that mother and child are now healthy.At present no knowledge or report about further patients details were made available.Additional details provided on 10dec2015: a balloon was placed in the cervix and after 5 minutes they observe fhr changes and bleeding.They performed an urgent cs and rescued alive baby.Operating doctor diagnosed total placental abruption.

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4943380
• MDR Text Key: 6196075
• Report Number: 1820334-2015-00465
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Model Number: N/A
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 5782856
• Other Device ID Number: UDI# (01)00827002198913(17)180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening