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

Catalog Number J-CRBS-184000

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

Patient Problem No Code Available (3191)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, a cook cervical ripening balloon w/stylet was used to dilate the cervix prior to induction of labor.Fetal presentation was cephalic prior to insertion of the device and after insertion of the device the fetus turned up into a podalic presentation.An "upheaval" of the fetus was performed to turn down the head of the fetus.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary: it was reported, a cook cervical ripening balloon w/stylet was used to dilate the cervix prior to induction of labor.Fetal presentation was cephalic prior to insertion of the device and after insertion of the device the fetus turned up into a podalic presentation.An "upheaval" of the fetus was performed to turn down the head of the fetus without success.A cesarean section(c-section) was performed.No additional patient consequences were reported.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation, and no lot number was provided.Accordingly, no physical examination or device history record review could be conducted.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which warn, ¿if spontaneous rupture of membranes occurs while the cook cervical ripening balloon is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery.¿ the ifu states that breech presentation is a contraindication for device use and that the need for caesarean delivery is a potential adverse event.Based on the available information, cook has concluded that the cause of the event cannot be traced to the device, but to patient condition.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received 15dec2020: the user facility reported that they do not believe the issue is related to the cook cervical ripening balloon w/stylet, but rather patient selection.

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10475879
• MDR Text Key: 205127809
• Report Number: 1820334-2020-01599
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention