MAUDE Adverse Event Report: COOK UROLOGICAL INC COOK CERVICAL RIPENING BALLOON WITH STYLER; HDY DILATER, CERVICAL

Catalog Number C-CRBS-184000

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 08/01/2013

Event Type  Injury  

Event Description

The physician working with a 2 year resident during a procedure in (b)(6) 2013 for cholestasis of pregnancy.The cervix was 2cm dilated.The physician passed the balloon with stylet in place through the internal os, filled the internal balloon to 30cc and then applied traction to make sure it was secure.The balloon was noted to be in the cervix and then heavy vaginal bleeding was noted.The balloon was again checked and noted to be in the cervix when a second large gush of bleeding occurred.The balloon was deflated and removed.The stylet and tubing were noted to be intact.The pt continued to hemorrhage from what appeared to be two abrasions in the cervix at 3 o'clock and 9 o'clock.No large lacerations were noted.Ring forceps were placed on these two areas with hemostatics noted.After approximately 10 minutes of pressure with ring forceps, the areas were hemostatic.The pt's labor course was otherwise uncomplicated and progressed to have a vaginal delivery without any cervical abnormalities noted after delivery.This was her third vaginal delivery.The baby had no abnormal fetal heart rate tracings throughout the hemorrhage or rest of her labor course.

Manufacturer Narrative

Event evaluation: still under investigation.

Manufacturer Narrative

The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.Investigation eval: during investigation, a review of complaint history, drawing, instructions for use (ifu) and quality control (qc) was conducted.The product was not returned for investigation.Incoming quality control personnel inspects this device per specification, ensuring the product is free of excess debris and discoloration and that the tip is round, smooth and free of flash.An instructions for use (ifu) is provided that warns "the stylet should only be used to traverse the tip of the catheter through the cervix and should be removed as soon as the uterine balloon is above the level of the internal uterine opening (internal os) prior to full insertion of the catheter.Aggressive insertion may result in injury to the baby." it also lists potential adverse events, including "cervical laceration" and "bleeding." the ifu also provides steps on a method to insert the catheter with the provided stylet.It should be noted that abrasions were present at 3 and 9 o'clock positions on the cervix.A procedural video found on the cookmedical.Com website shows the j-crb-184000 being inserted with ring forceps, held at the 3 and 9 o'clock position.It is reasonable to assume that while the device was being inserted, an instrument was holding the device and scaped the cervix at the 3 and 9 o'clock positions, causing the abrasions.Without further info or a confirmation on the use of a device during insertion, a root cause can not be determined with certainty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) additional risk reduction activities are not needed.

• Brand Name: COOK CERVICAL RIPENING BALLOON WITH STYLER
• Type of Device: HDY DILATER, CERVICAL
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3736003
• MDR Text Key: 4306515
• Report Number: 1820334-2014-00146
• Device Sequence Number: 1
• Product Code: HDY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-CRBS-184000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2013
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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