MAUDE Adverse Event Report: COOK INC COOK® CERVICAL RIPENING BALLOON; HDY DILATOR, CERVICAL

Model Number N/A

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Date 03/15/2015

Event Type  Injury  

Event Description

A study site reported that a (b)(6) year old female pt underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2015.The baseline clinical assessment revealed (b)(6) effacement, 2 cm dilation and -3 station.The cervix was posterior and soft.The crb was inserted on (b)(6) 2015 at 09:56.Insertion of the crb was considered very easy.The crb was removed at 12:49 and the cervix was dilated to 5 cm at that time.The pt received epidural anesthesia on (b)(6) 2015 beginning at 11:50.At 14:30 a vaginal exam revealed that the pt was 9 cm dilated and the cord was prolapsed.The pt was taken for c-section.The baby had low apgars at delivery and was admitted into nicu.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), and quality control was conducted during the investigation.The device was not returned to assist in the investigation.The ifu states appropriate uses, contraindications, warnings and precautions, potential adverse events including failed dilation or need for caesarean delivery, and proper usage instructions.There is no evidence to suggest that the device was not manufactured per specifications.It is unknown why the cord prolapse occurred, but the study facility marked that the device was unlikely related to the event.The device was removed approximately 1 hour and 40 minutes before discovering the cord prolapse.It was stated that the need to a c-section, was not due to the balloon.The complaint was confirmed based on customer testimony.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

A study site reported that a (b)(6) female patient underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2015.The baseline clinical assessment revealed 70% effacement, 2 cm dilation and -3 station.The cervix was posterior and soft.The crb was inserted on (b)(6) 2015 at 09:56.Insertion of the crb was considered very easy.The crb was removed at 12:49 and the cervix was dilated to 5 cm at that time.The patient received epidural anesthesia on (b)(6) 2015 beginning at 11:50.At 14:30 a vaginal exam revealed that the patient was 9 cm dilated and the cord was prolapsed.The patient was taken for c-section.The baby had low apgars at delivery and was admitted into nicu.On 27-apr-2015 the site submitted an event form and indicated that this event was unlikely related to either the study device or study procedure.

• Brand Name: COOK® CERVICAL RIPENING BALLOON
• Type of Device: HDY DILATOR, CERVICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4713516
• MDR Text Key: 5649423
• Report Number: 1820334-2015-00263
• 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: Study,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CRB-184000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2015
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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): Other
• Patient Age: 23 YR