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U.S. Department of Health and Human Services

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

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COOK INC COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA Back to Search Results
Catalog Number J-CRBS-184000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
Event date: 2020.A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, an instance of cord prolapse was observed after using a cook cervical ripening balloon w/stylet.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
Additional information was received 22feb2021: as reported, the device was being used pre-induction of labor.There was no malfunction of the device.The balloons were inflated 60 to 80 ml with sterile water.There is no information available on the date of event, lot number, or how long the device was in place.The patient had an emergency cesarean section (c-section).There was no harm to the patient other than cesarean delivery.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Event summary: as reported, an instance of cord prolapse was observed after using a cook cervical ripening balloon w/stylet.The device was being used pre-induction of labor.There was no malfunction of the device.The balloons were inflated 60 to 80 ml with sterile water.There is no information available on the date of event, lot number, or how long the device was in place.The patient had an emergency cesarean section (c-section).There was no harm to the patient other than cesarean delivery.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.Accordingly, no physical examination was performed.As the product lot was not provided, reviews of complaint history and the device history record could not be conducted.There were no identified gaps in the quality control procedures.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The instructions for use provided with the device include prolapsed umbilical cord and ruptured membranes as contraindications for the device.The ifu also warns, "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." based on available evidence, cook has concluded that the cause of this event cannot be traced to the device.Cook will continue 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.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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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 Key11293827
MDR Text Key230747707
Report Number1820334-2021-00274
Device Sequence Number1
Product Code PFJ
Combination Product (y/n)N
PMA/PMN Number
K131206
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberJ-CRBS-184000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/08/2021
Supplement Dates Manufacturer Received02/22/2021
03/25/2021
Supplement Dates FDA Received03/04/2021
03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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