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

Model Number G24237

Device Problem Material Rupture (1546)

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

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

E1: customer postal code/ phone = (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 patient had bleeding following a cesarean section and had lost ~500ml of blood.A 'cook bakri postpartum balloon with rapid instillation components' was placed transabdominally in an attempt to stop the bleeding.The balloon was inflated with approximately 300ml of water before the balloon ruptured.The balloon was not inflated prior to the closure of the hysterotomy.The user replaced the device with another balloon and hemostasis was achieved.The patient lost an additional ~800ml of blood following the device issue; the total estimated blood loss was ~1300ml.The patient required a blood transfusion, it is unknown how many units were transfused.The device was not handled by or in the proximity of any metal tools (i.E., forceps or suture needles) that may have damaged the balloon.The patient was hemodynamically stable.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported by shenzhen inlife sci.Co.,ltd.On (b)(6)2023, a patient had bleeding following a cesarean section and had lost ~500ml of blood.A 'cook bakri postpartum balloon with rapid instillation components' (rpn: (b)(4); lot:14433619) was placed transabdominally in an attempt to stop the bleeding.The balloon was inflated with approximately 300ml of water before the balloon ruptured.The balloon was not inflated prior to the closure of the hysterotomy.The user replaced the device with another balloon and hemostasis was achieved.The patient lost an additional ~800ml of blood following the device issue; the total estimated blood loss was ~1300ml.The patient required a blood transfusion, it is unknown how many units were transfused.The device was not handled by or in the proximity of any metal tools (i.E., forceps or suture needles) that may have damaged the balloon.The patient was hemodynamically stable.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One used cook bakri postpartum balloon with rapid instillation components device with no original packaging was returned for investigation and a visual inspection was conducted.Device failure analysis found the balloon material was split the entire length of the balloon.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 search of the device history record found no related non-conformances reported for lot 14433619 and related subassembly lots.A complaint history database search showed no other related complaints associated with the complaint device lot.Because there are 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 field.There is no evidence to suggest this device was manufactured out of specification.Cook also reviewed product labeling.The ifu (t_j-sosr_rev4; ¿bakri postpartum balloon¿) supplied with the device states the following in consideration of the reported failure mode: - precautions: ¿avoid excessive force when inserting the balloon into the uterus.¿ - how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified.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 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: 17195557
• MDR Text Key: 317811831
• Report Number: 1820334-2023-00811
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)241221(10)14433619
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14433619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 60 KG