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 Problems Bacterial Infection (1735); Death (1802)

Event Date 06/03/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

A female patient of unknown age was at term in her pregnancy with a small for gestational age (sga) fetus.The patient had a previous caesarean section.For induction of labor, a cook cervical ripening balloon was inserted for 12 hours.Upon removal of the balloon, the physician waited another 19 hours before attempting to rupture the membrane, but it was not possible as the cervix was closed.A caesarean section was scheduled to be done in 48 hours.The patient returned a few hours before the scheduled procedure with fever and ultimately a fetal death in-utero.The patient tested positive for a staph.Aureus infection.The autopsy of the fetus indicated the same staph.Aureus infection in its lung, spleen and blood.There was also evidence of a chorioamnionitis infection.A copy of the autopsy has been requested.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient experienced adverse effects due to this occurrence: fever & fetal death in-utero.

Manufacturer Narrative

(b)(4).Investigation - evaluation : a review of the complaint history, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known, accordingly a review of the device manufacturing records could not be conducted.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: ¿the product should not be left indwelling for a period greater than 12 hours.¿ the product is "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred." the ifu also contraindicates use of this device in patients who have had previous full-thickness uterine incisions such as previous caesareans, which was the case with this patient.The ifu also lists potential adverse events including failed dilation or need for caesarean delivery.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

A female patient of unknown age was at term in her pregnancy with a small for gestational age (sga) fetus.The patient had a previous caesarean section.For induction of labor, a cook cervical ripening balloon was inserted for 12 hours.Upon removal of the balloon, the physician waited another 19 hours before attempting to rupture the membrane, but it was not possible as the cervix was closed.A caesarean section was scheduled to be done in 48 hours.The patient returned a few hours before the scheduled procedure with fever and ultimately a fetal death in-utero.The patient tested positive for a staph.Aureus infection.The autopsy of the fetus indicated the same staph.Aureus infection in its lung, spleen and blood.There was also evidence of a chorioamnionitis infection.A copy of the autopsy has been requested.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient experienced adverse effects due to this occurrence: fever & fetal death in-utero.

• 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: 5882125
• MDR Text Key: 52297653
• Report Number: 1820334-2016-00892
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CRB-184000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• 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): Death