MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number	G30673
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the hospital delivery room that the patient was admitted for delivery on (b)(6) 2024 following 40 weeks of amenorrhea.The patient experienced significant bleeding of 960 ml after cesarean section on (b)(6) 2024, with poor uterine contractions and a total of 1000+ml.The patient was given a bakri tamponade balloon catheter as treatment for postpartum hemorrhage [pph] secondary to uterine atony.The balloon was placed by hand, transabdominally, and the uterus was sutured.When injecting 300 ml of normal saline, it was found that there was leakage of saline from the catheter.The total estimated blood loss was too small to determine.The bakri balloon was not used.Medical staff immediately replaced the bakri balloon to complete the procedure.This delayed the rescue time, increased postpartum bleeding, and repeated uterine cavity operations could easily cause uterine cavity infections, the contractile agent was strengthened but the effect of contraction promotion was not good, the device was not tested before use and the device was not handled by or in the proximity of any metal tools that may have damaged the balloon.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No blood transfusion was performed.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - name and address: phone: (b)(6).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.
Additional Manufacturer Narrative
Investigation evaluation description of event: it was reported by the hospital delivery room that the patient was admitted for delivery on (b)(6) 2024 following 40 weeks of amenorrhea.The patient experienced significant bleeding of 960 ml after cesarean section on (b)(6) 2024, with poor uterine contractions and a total of 1000+ml.The patient was given a bakri tamponade balloon catheter as treatment for postpartum hemorrhage [pph] secondary to uterine atony.The balloon was placed by hand, transabdominally, and the uterus was sutured.When injecting 300 ml of normal saline, it was found that there was leakage of saline from the catheter.The total estimated blood loss was too small to determine.The bakri balloon was not used.Medical staff immediately replaced the bakri balloon to complete the procedure.This delayed the rescue time, increased postpartum bleeding, and repeated uterine cavity operations could easily cause uterine cavity infections, the contractile agent was strengthened but the effect of contraction promotion was not good, the device was not tested before use and the device was not handled by or in the proximity of any metal tools that may have damaged the balloon.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No blood transfusion was performed.The complainant has not reported any adverse effects on the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures, a visual inspection, and functional test of the returned device, were conducted during the investigation.One bakri tamponade balloon catheter was returned in an open package with label.Water was inflated into the balloon, and a leak was observed near the hub.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was performed and related nonconformance's were identified and scrapped prior to distribution.Therefore, it is unlikely this issue affects the entire lot.A review of complaint history records shows no other related complaints associated with device lot.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product 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." cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Common Device Name: 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: 20689650
• Report Number: 1820334-2024-01490
• Device Sequence Number: 15628435
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)270502(10)16039891
• Combination Product (Y/N): N
• PMA/510(K) Number: K170622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 16039891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female