MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Inflation Problem (1310)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 09/16/2021

Event Type  Injury  

Event Description

As reported, a cook bakri postpartum balloon with rapid instillation components did not work when it was going to be used.The bakri was removed from the patient.Additional patient outcome and event information has been requested.

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a cook bakri postpartum balloon with rapid instillation components did not work when it was going to be used.The bakri was removed from the patient.Additional patient outcome and event information has been requested.

Manufacturer Narrative

Additional information: b1, b2, b5, e4, h1, h6 (annexes e and f).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 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

Additional information was received 24mar2022.The patient had no prior gestational history.The patient had history of disseminated intravascular coagulation.The post-partum hemorrhage was secondary to uterine atony.The device was placed transabdominally immediately after delivery and was attempted to be inflated using the rapid-installation components.The device was not handled by or in the proximity of metal tools.The device was unable to be inflated due to a "defective ball" and was quickly removed.The patient lost between 1000ml and 1500ml of blood in total.The patient was transferred to surgery for hysterectomy and received one unit red blood cells, four units plasma, and three units cryoprecipitate.The patient was hospitalized in intensive care post-surgery.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, a cook bakri postpartum balloon with rapid instillation components did not inflate.The patient had no prior gestational history.The patient had history of disseminated intravascular coagulation.The post-partum hemorrhage was secondary to uterine atony.The device was placed transabdominally immediately after delivery and was attempted to be inflated using the rapid-installation components.The device was not handled by or in the proximity of metal tools.The device was unable to be inflated due to a "defective ball" and was quickly removed.The patient lost between 1000ml and 1500ml of blood in total.The patient was transferred to surgery for hysterectomy and received one unit red blood cells, four units plasma, and three units cryoprecipitate.The patient was hospitalized in intensive care post-surgery.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which warn, "patients in whom this device is being used should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation (dic).In such cases, emergency intervention per hospital protocol should be followed," and, "there are no clinical data to support use of this device in the setting of dic." the ifu also states, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that the most probable cause of the reported inability of the device to inflate could not be determined.The patient was reported to have had contraindicating comorbidities that would have likely led to moderate to severe postpartum hemorrhage despite device success or failure.Cook will continue monitoring of similar complaints and has 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.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13505397
• MDR Text Key: 285393176
• Report Number: 1820334-2022-00193
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)240110(10)13677307
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 13677307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2021
• 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): Hospitalization; Required Intervention
• Patient Sex: Female