MAUDE Adverse Event Report: COOK INC COOK® CERVICAL RIPENING BALLOON; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Model Number N/A

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

Patient Problem Prolapse (2475)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A study site for cervical ripening balloon (crb) in premature rupture of fetal membranes (prom) reported that a (b)(6) female underwent labor induction with a cervical ripening balloon (crb) and pitocin with cord prolapse.The baseline clinical assessment revealed 40-50% effacement, 1-2 cm dilation and -3 station, the cervix was posterior and soft.The crb was inserted on (b)(6) 2016 at 11:07, with vaginal balloon 30 ml of saline and uterine balloon 60 ml of saline.Insertion of the crb was considered neither easy nor difficult., pitocin was reportedly started at 11:15.At approximately 6 hours following the start of pitocin, a patient assessment revealed 40-50% effacement, 5+ cm dilation and -3 station.A sonogram, done at 18:32, confirmed vertex (head down) presentation in triage.The crb fell out at 17:34 after achieving the desired cervical dilation.The patient was initially taken to the operating room (or) at 19:25, however, there was an emergency with another patient; the study patient was returned to their room in labor in delivery (l & d).The study patient returned to surgery and spinal anesthesia was started at 21:17.The patient received epidural anesthesia beginning at 19:52, there was a note in the anesthesia record at 21:26 that the umbilical cord was hanging from the vagina.Delivery occurred by c-section at 21:32.Reportedly the device did not malfunction or deteriorate in characteristics or performance and the event was not considered serious.The baby had a one minute american pediatric gross assessment record (apgar) score of 7 and a 5 minute score of 9.The newborn required no immediate care and was admitted to the nursery.Both mother and baby were discharged on (b)(6) 2016, four days post-delivery.

Manufacturer Narrative

A review of the complaint history, drawings, device history record, instructions for use (ifu), and specifications was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were two other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: COOK® CERVICAL RIPENING BALLOON
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5853878
• MDR Text Key: 51384942
• Report Number: 1820334-2016-00745
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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-CI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• 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): Required Intervention
• Patient Age: 27 YR