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

Catalog Number J-SOSR-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).E3: customer occupation = unknown 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

As reported, a female patient was being treated for postpartum hemorrhage following a cesarean section delivery.The user deployed a 'cook bakri postpartum balloon with rapid instillation components' device and found that the balloon was perforated and was leaking during attempted inflation.Uterine compression was also used in an attempt to treat the postpartum hemorrhage.The patient did not require any additional intervention due to this occurrence.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details, how the procedure was completed, and blood loss has been requested but is not available at this time.

Manufacturer Narrative

B5: additional information received 07dec2023.Investigation evaluation submitted with under mdr on 19oct2023; no updates to the investigation are necessary at this time.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 info received 07dec2023: total estimated blood loss (ebl) was not calculated.It was noted upon inflation that the device leaked from the balloon.The patient did not require any blood transfusions.The procedure was completed by using another bakri device.No tools were used to place the device.

Event Description

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

Manufacturer Narrative

Correction: d9, h3, h6 (annex b), h10 investigation - evaluation as reported, a female patient was being treated for postpartum hemorrhage following a cesarean section delivery.The user deployed a 'cook bakri postpartum balloon with rapid instillation components' device and found that the balloon was perforated and was leaking during attempted inflation.No tools were used to place the device.The procedure was completed by using another bakri device.Uterine compression was also used in an attempt to treat the postpartum hemorrhage.The patient did not require any blood transfusions.The patient did not require any additional intervention due to this occurrence.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.A visual inspection and functional test of the device were conducted.The complaint device was returned to cook for evaluation.The device was function tested by inflating with water.A small leak in the balloon was observed.Under magnification, a pressure mark in the balloon was noted in the balloon material at the leak.Based on the information provided, the returned device, and the results of the investigation, a definitive cause of the event could not be determined.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Corrected information: d9 and h3.Event description: a representative of g.Barco s.A.Informed cook on 28jul2023 of an incident involving a cook bakri postpartum balloon with rapid installation components (j-sosr-100500) from production lot 13562706.As reported, a female patient was being treated for postpartum hemorrhage following a cesarean section delivery.The user deployed the device and found that the balloon was perforated and was leaking during attempted inflation.Uterine compression was also used in an attempt to treat the postpartum hemorrhage.The patient did not require any additional intervention due to this occurrence.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details, how the procedure was completed and blood loss, has been requested but not provided.Investigation - evaluation reviews of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device were 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 this device was manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned device, and the results of the investigation, a definitive cause of the event could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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

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

• 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: 17603282
• MDR Text Key: 321739385
• Report Number: 1820334-2023-01138
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)231117(10)13562706
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 13562706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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 Age: 33 YR
• Patient Sex: Female