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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that the stopcock of a bakri tamponade balloon catheter was found in the patient, by the patient, several days after device use.The device was deployed vaginally following an uncomplicated vaginal delivery.Within 24 hours after successful device placement, the balloon was deflated with a syringe by the same user who placed the device, the device was removed from the patient and discarded.It was reported that the stopcock was not removed from the device at any point during use.The patient was discharged as normal.After 'several' days, the patient then presented to the emergency department with complaints of abdominal pain and claiming she had removed the stopcock vaginally at home.The patient was then discharged from the emergency department with no further pain or additional physical findings.It was reported that the clinicians felt that the stopcock could not have been left in the patient by the user on accident, as the stopcock was never detached from the device.The clinicians suspect the stopcock was deliberately placed through manual insertion.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer postal code = (b)(6).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.

Manufacturer Narrative

Corrected information: b3 - exact date of event is unknown.Event occurred in jan 2023 (01jan2023 - 26jan2023) information was available but inadvertently omitted from the previous medwatch report.Event description: it was reported that the stopcock of a bakri tamponade balloon catheter was found in the patient, by the patient, several days after device use.The device was deployed vaginally following an uncomplicated vaginal delivery.Within 24 hours after successful device placement, the balloon was deflated with a syringe by the same user who placed the device, the device was removed from the patient and discarded.It was reported that the stopcock was not removed from the device at any point during use.The patient was discharged as normal.After 'several' days, the patient then presented to the emergency department with complaints of abdominal pain and claiming she had removed the stopcock vaginally at home.The patient was then discharged from the emergency department with no further pain or additional physical findings.It was reported that the clinicians felt that the stopcock could not have been left in the patient by the user on accident, as the stopcock was never detached from the device.The clinicians suspect the stopcock was deliberately placed through manual insertion.Investigation - evaluation: reviews of instructions for use (ifu) and quality control procedures 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 evidence to suggest the product was made to specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.A review of relevant manufacturing and quality control 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.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: instructions for use "transvaginal placement 1.Determine uterine volume by direct examination or ultrasound examination.2.Insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium.3.Place an indwelling urinary bladder foley catheter at this time, if not already in place, to collect and monitor uterine output." the most probable cause of the reported event could not be determined from the available information.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.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.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• 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: 16315921
• MDR Text Key: 309019082
• Report Number: 1820334-2023-00110
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Sex: Female